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PT. MAIN MEDICAL CHAKRA

Authorized Representative in Indonesia

FORESTA BUSINESS LOFT 6 No. 10, Jl. Raya Boulevard Utara BSD City, Desa/Kelurahan Lengkong Kulon
128 Products Represented
35 Manufacturers
Total Products
128
Manufacturers
35
Product Classes
3
Risk Classes
4
Risk Classification Breakdown
Distribution of represented products across risk classes
Kelas Resiko : A
10 products
7.8%
Kelas Resiko : B
81 products
63.3%
Kelas Resiko : C
33 products
25.8%
Kelas Resiko : D
4 products
3.1%
Manufacturer Portfolio
Products organized by manufacturer
All Represented Products (128)
Complete portfolio registered with BPOM

VivaDiag™ Progesterone Test Kit (FIA)

Manufacturer:

VIVACHEK BIOTECH (HANGZHOU) CO., LTD., CHINA.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 24, 2025

VivaDiag™ Free Thyroxine Control Solution (FIA)

Manufacturer:

VIVACHEK BIOTECH (HANGZHOU) CO., LTD., CHINA.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 17, 2025

VivaDiag™ Free Triiodothyronine Control Solution (FIA)

Manufacturer:

VIVACHEK BIOTECH (HANGZHOU) CO., LTD., CHINA.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 15, 2025

VivaDiag™ Testosterone Test Kit (FIA)

Manufacturer:

VIVACHEK BIOTECH (HANGZHOU) CO., LTD., CHINA.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 4, 2025

BALIO - CLE-P Cleanser

Manufacturer:

SHENZHEN DYMIND BIOTECHNOLOGY CO.,LTD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 17, 2024

CITEST Multi-Drug 6 Drugs Rapid Test Panel (Urine) (MOP300/COC300/AMP1000/MET1000/THC50/BZO300)

Manufacturer:

CITEST DIAGNOSTICS INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 31, 2024

VivaDiag Glycosylated Hemoglobin Control Solution

Manufacturer:

VIVACHEK BIOTECH (HANGZHOU) CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 30, 2024

CITEST™ Urine Analyzer AUR-200 and Accessories

Manufacturer:

HANGZHOU ALLTEST BIOTECH CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 18, 2024

VivaDiag™ POCT Analyzer VIM3000

Manufacturer:

VIVACHEK BIOTECH (HANGZHOU) CO., LTD., CHINA.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 9, 2024

CITEST™ Urinalysis Reagent Strips - 10U (Urine) (LEU/NIT/URO/PRO/pH/BLO/SG/KET/BIL/GLU)

Manufacturer:

HANGZHOU ALLTEST BIOTECH CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 2, 2024

CITEST Multi Drug 7 Drugs Rapid Test 1-Step Cup (Urine) (THC50, MET1000, MOP300, AMP1000, BZO300, K250, CAR2000)

Manufacturer:

HANGZHOU ALLTEST BIOTECH CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 31, 2024

CITEST Multi Drug 10 Drugs Rapid Test Panel (Urine) (MOP300, MDMA500, COC300, THC50, AMP500, MET500, MTD300, BAR300, BZO300, BUP10)

Manufacturer:

HANGZHOU ALLTEST BIOTECH CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 31, 2024

CITEST Multi Drug 6 Drugs Rapid Test Panel (Urine) (OPI300/MDMA500/COC300/AMP500/MET500/THC50)

Manufacturer:

HANGZHOU ALLTEST BIOTECH CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 31, 2024

CITEST Multi Drug 6 Drugs Rapid Test Cassette (AMP500/COC300/THC50/MET500/MOP300/BZO300)

Manufacturer:

HANGZHOU ALLTEST BIOTECH CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 27, 2024

CITEST Multi Drug 7 Drugs Rapid Test Cassette (AMP500/COC300/THC50/MET500/MOP300/MDMA500/MTD300)

Manufacturer:

HANGZHOU ALLTEST BIOTECH CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 27, 2024

CITEST Multi Drug 3 Drugs Rapid Test Panel (Urine) (AMP500,COC300,THC50)

Manufacturer:

HANGZHOU ALLTEST BIOTECH CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 27, 2024

VivaDiag Free Triiodothyronine Test Kit (FIA)

Manufacturer:

VIVACHEK BIOTECH (HANGZHOU) CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 13, 2024

VivaDiag™ Carcino-embryonic Antigen Test Kit (FIA)

Manufacturer:

VIVACHEK BIOTECH (HANGZHOU) CO., LTD., CHINA.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 13, 2024

BALIO Hematology Analyzer Lyse LYC-2

Manufacturer:

SHENZHEN DYMIND BIOTECHNOLOGY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 5, 2024

BALIO OX580 Auto Hematology Analyzer and Accesories

Manufacturer:

SHENZHEN DYMIND BIOTECHNOLOGY CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 5, 2024

BALIO OX560 Auto Hematology Analyzer and Accesories

Manufacturer:

SHENZHEN DYMIND BIOTECHNOLOGY CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 1, 2024

BALIO Hematology Analyzer Lyse LYA-2

Manufacturer:

SHENZHEN DYMIND BIOTECHNOLOGY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 26, 2024

BALIO DIL C Diluent 560.20

Manufacturer:

SHENZHEN DYMIND BIOTECHNOLOGY CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 25, 2024

BALIO - Hematology Analyzer Lyse LYC-1

Manufacturer:

SHENZHEN DYMIND BIOTECHNOLOGY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 25, 2024

BALIO Hematolgy Analyzer Lyse LYA-3

Manufacturer:

SHENZHEN DYMIND BIOTECHNOLOGY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 22, 2024

BALIO DIL-A Diluent 580.20

Manufacturer:

SHENZHEN DYMIND BIOTECHNOLOGY CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 21, 2024

VALUES - Diluent 360.20

Manufacturer:

SHENZHEN LICARE BIOMEDICAL TECHNOLOGY CO. LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 17, 2024

BALIO OX360 Auto Hematology Analyzer and Accesories

Manufacturer:

SHENZHEN LICARE BIOMEDICAL TECHNOLOGY CO. LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 17, 2024

BALIO Hematology Analyzer Lyse LYA-1

Manufacturer:

SHENZHEN DYMIND BIOTECHNOLOGY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 17, 2024

BALIO - Probe Cleaner 360.01

Manufacturer:

SHENZHEN LICARE BIOMEDICAL TECHNOLOGY CO. LTD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Feb 13, 2024

BALIO - Cleaner 360.5

Manufacturer:

SHENZHEN LICARE BIOMEDICAL TECHNOLOGY CO. LTD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Feb 13, 2024

BALIO - Concentrated Cleaner 360.02

Manufacturer:

SHENZHEN LICARE BIOMEDICAL TECHNOLOGY CO. LTD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Feb 2, 2024

VALUES - Lyse 360.05

Manufacturer:

SHENZHEN LICARE BIOMEDICAL TECHNOLOGY CO. LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 1, 2024

VivaDiag Morphine Test Kit (FIA)

Manufacturer:

VIVACHEK BIOTECH (HANGZHOU) CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 29, 2023

VivaDiag ™ Luteinising Hormone Control Solution (FIA)

Manufacturer:

VIVACHEK BIOTECH (HANGZHOU) CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 4, 2023

VivaDiag Myoglobin Control Solution (FIA)

Manufacturer:

VIVACHEK BIOTECH (HANGZHOU) CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 29, 2023

VivaDiag ™ Ferritin Control Solution (FIA)

Manufacturer:

VIVACHEK BIOTECH (HANGZHOU) CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 24, 2023

VivaDiag Creatine Kinase-MB Control Solution (FIA)

Manufacturer:

VIVACHEK BIOTECH (HANGZHOU) CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 22, 2023

VivaDiag Thyroxine Control Solution (FIA)

Manufacturer:

VIVACHEK BIOTECH (HANGZHOU) CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 20, 2023

VivaDiag Triiodothyronine Control Solution (FIA)

Manufacturer:

VIVACHEK BIOTECH (HANGZHOU) CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 20, 2023

VivaDiag Micro Albuminuria Control Solution (FIA)

Manufacturer:

VIVACHEK BIOTECH (HANGZHOU) CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 18, 2023

MIURA ONE Clinical Chemistry Autoanalyzer and Accessories

Manufacturer:

I.S.E S.r.l.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 18, 2023

VivaDiag Thyroid Stimulating Hormone Control Solution (FIA)

Manufacturer:

VIVACHEK BIOTECH (HANGZHOU) CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 13, 2023

VivaDiag Cardiac Troponin I Control Solution (FIA)

Manufacturer:

VIVACHEK BIOTECH (HANGZHOU) CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 13, 2023

VivaDiag 25-Hydroxyvitamin D3 (25-OH-D3) Test Kit (FIA)

Manufacturer:

VIVACHEK BIOTECH (HANGZHOU) CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 10, 2023

VivaDiag™ Procalcitonin Control Solution (FIA)

Manufacturer:

VIVACHEK BIOTECH (HANGZHOU) CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 8, 2023

VivaDiag™ Neutropil Gelatinase-associated Lipocalin Test Kit (FIA)

Manufacturer:

VIVACHEK BIOTECH (HANGZHOU) CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 22, 2023

VivaDiag™ D-Dimer Control Solution (FIA)

Manufacturer:

VIVACHEK BIOTECH (HANGZHOU) CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 21, 2023

VivaDiag™ Procalcitonin Test Kit (FIA)

Manufacturer:

VIVACHEK BIOTECH (HANGZHOU) CO.,LTD.,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 9, 2023

VIVADIAG ™ Serum Amyloid A Protein Test Kit (FIA)

Manufacturer:

VIVACHEK BIOTECH (HANGZHOU) CO., LTD.,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 9, 2023

VivaDiag™ Heart Fatty Acid Binding Protein Test Kit (FIA)

Manufacturer:

VIVACHEK BIOTECH (HANGZHOU) CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 9, 2023

VIVADIAG™ N-terminal Pro-brain Natriuretic Peptide Test Kit (FIA)

Manufacturer:

VIVACHEK BIOTECH (HANGZHOU) CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 7, 2023

VIVADIAG™ Myoglobin Test Kit (FIA)

Manufacturer:

VIVACHEK BIOTECH (HANGZHOU) CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 26, 2023

SUNWAY Vacuum Blood Collection System 3.2 % Sodium Citrate Tube (PET)

Manufacturer:

WEIHAI SUNWAY MEDICAL TECHNOLOGY CO.,LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 24, 2023

MIURA Double ARM Models and Accessories

Manufacturer:

I.S.E. S.R.L.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jul 20, 2023

VIVADIAG ™ Luteinising Hormone Test Kit (FIA)

Manufacturer:

VIVACHEK BIOTECH (HANGZHOU) CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 18, 2023

CITEST™ Urine Analyzer AUR – CT100 and Accessories

Manufacturer:

HANGZHOU ALLTEST BIOTECH CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 18, 2023

SUNWAY Vacuum Blood Collection System EDTA K3 Tube (PET)

Manufacturer:

WEIHAI SUNWAY MEDICAL TECHNOLOGY CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 18, 2023

SUNWAY Vacuum Blood Collection System Gel & Clot Activator Tube

Manufacturer:

WEIHAI SUNWAY MEDICAL TECHNOLOGY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 17, 2023

VivaDiag Beta-2 Microglobulin Test Kit (FIA)

Manufacturer:

VIVACHEK BIOTECH (HANGZHOU) CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 7, 2023

VIVADIAG™ Creatine Kinase-MB Test Kit (FIA)

Manufacturer:

VIVACHEK BIOTECH (HANGZHOU) CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 6, 2023

VIVADIAG ™ Cystatin C Test Kit (FIA)

Manufacturer:

VIVACHEK BIOTECH (HANGZHOU) CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 30, 2023

VIVADIAG ™ Cardiac Troponin I Test Kit (FIA)

Manufacturer:

VIVACHEK BIOTECH (HANGZHOU) CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 26, 2023

VIVADIAG™ Thyroxine Test Kit (FIA)

Manufacturer:

VIVACHEK BIOTECH (HANGZHOU) CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 26, 2023

VIVADIAG ™ Micro Albuminuria Test Kit (FIA)

Manufacturer:

VIVACHEK BIOTECH (HANGZHOU) CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 26, 2023

VIVADIAG ™ Beta Human Chorionic Gonadotropin Test Kit (FIA)

Manufacturer:

VIVACHEK BIOTECH (HANGZHOU) CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 26, 2023

VivaDiag Triiodothyronine Test Kit FIA

Manufacturer:

VIVACHEK BIOTECH (HANGZHOU) CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 21, 2023

BRIGHTNESS Disposable Circular Stapler

Manufacturer:

JIANSU BRIGHTNESS MEDICAL DEVICES CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 19, 2023

VIVADIAG™ Ferritin Test Kit (FIA)

Manufacturer:

VIVACHEK BIOTECH (HANGZHOU) CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 16, 2023

BRIGHTNESS Disposable Auto Linear Stapler & Cartridge

Manufacturer:

JIANGSU BRIGHTNESS MEDICAL DEVICES CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 13, 2023

BRIGHTNESS Disposable Endocutter & Cartridge

Manufacturer:

JIANGSU BRIGHTNESS MEDICAL DEVICES CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 13, 2023

VivaDiag™ Glycosylated Hemoglobin Test Kit (FIA)

Manufacturer:

VIVACHEK BIOTECH (HANGZHOU) CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 11, 2023

VIVADIAG ™ Whole C-Reactive Protein Test Kit (FIA)

Manufacturer:

VIVACHEK BIOTECH (HANGZHOU) CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 11, 2023

VivaDiag™ D-Dimer Test Kit (FIA)

Manufacturer:

VIVACHEK BIOTECH (HANGZHOU) CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 11, 2023

VivaDiag™ Thyroid Stimulating Hormone Test Kit (FIA)

Manufacturer:

VIVACHEK BIOTECH (HANGZHOU) CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 7, 2023

BRIGHTNESS Disposable Hemorrhoids Stapler

Manufacturer:

JIANGSU BRIGHTNESS MEDICAL DEVICES CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 24, 2023

CITEST Malaria P.f./P.v. Rapid Test Cassette (Whole Blood)

Manufacturer:

CITEST DIAGNOSTICS INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 26, 2023

CITEST Malaria P.f./Pan Rapid Test Cassette (whole Blood)

Manufacturer:

CITEST DIAGNOSTICS INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 9, 2023

CITEST Malaria P.f./P.v./Pan Rapid Test Cassette (Whole Blood)

Manufacturer:

CITEST DIAGNOSTICS INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 2, 2023

CITEST Multi-Drug 10 Drugs Rapid Test 1-Step Cup (Urine) (OPI/MDMA/COC/PCP/MTD/BZO/AMP/MET/CAR/THC)

Manufacturer:

CITEST DIAGNOSTICS INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 2, 2023

MEDSUN Blood Lancet for Single Use

Manufacturer:

NINGBO MEDSUN MEDICAL CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Feb 1, 2023

CITEST Multi-Drug 7 Drugs Rapid Test Panel (Urine) (MOP/MET/COC/BZO/AMP/THC/CAR)

Manufacturer:

CITEST DIAGNOSTICS INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 25, 2023

MEDSUN Blood Lancet for Single Use

Manufacturer:

NINGBO MEDSUN MEDICAL CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jan 25, 2023

PRODIGY AUTOCODE Blood Glucose Meter and Accessories

Manufacturer:

OK BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 30, 2022

PRODIGY Blood Glucose Test Strips

Manufacturer:

OK BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 29, 2022

VivaDiag Fecal Occult Blood Test Kit

Manufacturer:

VIVACHEK BIOTECH (HANGZHOU) CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 5, 2022

VIVADIAG Cardiac Troponin T Test Kit

Manufacturer:

VIVACHEK BIOTECH (HANGZHOU) CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 28, 2022

VivaDiag ™ Total Immunoglobulin E Test Kit

Manufacturer:

VIVACHEK BIOTECH (HANGZHOU) CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 25, 2022

MEDSUN Lancing Device CX11

Manufacturer:

NINGBO MEDSUN MEDICAL CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 18, 2022

VivaDiag ™ POCT Analyzer (VIM02)

Manufacturer:

VIVACHEK BIOTECH (HANGZHOU) CO., LTD., CHINA

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 27, 2022

EMPSUN Biochemistry Analyzer EMP-168 and Accessories

Manufacturer:

CHENGDU EMPSUN MEDICAL TECHNOLOGY CO.,LTD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jul 20, 2022

RAPIDAN Tester HBsAg Test, WB/S/P

Manufacturer:

TURKLAB TIBBI MALZEMELERI SAN, TIC. A.S

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Dec 27, 2021

RAPIDAN TESTER Anti-HCV Test, WB/S/P

Manufacturer:

TURKLAB TIBBI MALZEMELERI SAN, TIC. A.S

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Dec 27, 2021

RAPIDAN Tester Anti-HBs Test, WB/S/P

Manufacturer:

TURKLAB TIBBI MALZEMELERI SAN.,TIC. A.S.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Dec 27, 2021

RAPIDAN TESTER Malaria Test

Manufacturer:

TURKLAB TIBBI MALZEMELERI SAN, TIC. A.S.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 25, 2021

RAPIDAN TESTER Anti-HIV 1/2 Test ( WB/S/P )

Manufacturer:

TURKLAB TIBBI MALZEMELERI SAN, TIC. A.S.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Dec 17, 2021

VivaDiag™ Serum Amyloid A Control Solution

Manufacturer:

VIVACHEK BIOTECH (HANGZHOU) CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 15, 2021

RAPIDAN Tester hCG Cassette (Urine/Serum) Test

Manufacturer:

TURKLAB TIBBI MALZEMELERI SAN. VE TIC. A.S.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 13, 2021

RAPIDAN TESTER Fecal Occult Blood (FOB) Test

Manufacturer:

TURKLAB TIBBI MALZEMELERI SAN. T.C. Inc.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 13, 2021

RAPIDAN Tester Dengue IgG/IgM Test

Manufacturer:

TURKLAB TIBBI MALZEMELERI SAN, TIC. A.S.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 9, 2021

RAPIDAN TESTER Rotavirus Test

Manufacturer:

TURKLAB TIBBI MALZEMELERI SAN. T.C. Inc.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 8, 2021

RAPIDAN Tester Tuberculosis Test, WB/S/P

Manufacturer:

TURKLAB TIBBI MALZEMELERI SAN, TIC. A.S.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 8, 2021

RAPIDAN TESTER Gonorrhea Test

Manufacturer:

TURKLAB TIBBI MALZEMELERI SAN, TIC. A.S.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 5, 2021

RAPIDAN TESTER Anti-Syphilis Test, WB/S/P

Manufacturer:

TURKLAB TIBBI MALZEMELERI SAN TIC. A.S.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 5, 2021

RAPIDAN TESTER Dengue NS1 and IgG/IgM Test

Manufacturer:

TURKLAB TIBBI MALZEMELERI SAN TIC. A.S.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 5, 2021

SICHUAN XINCHENG MYO,CK-MB and cTnI Triple Card Assay Kit by Immunofluorescence Chromatography Method

Manufacturer:

SICHUAN XINCHENG BIOLOGICAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 14, 2021

VivaDiag™ POCT Analyzer and Accessories

Manufacturer:

VIVACHEK BIOTECH (HANGZHOU) CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 10, 2021

VIVADIAG™ Cystatin C Control Solution

Manufacturer:

VIVACHEK BIOTECH (HANGZHOU) CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 3, 2021

SICHUAN XINCHENG Serum Amyloid A Assay Kit by Immunofluorescence Chromatography Method

Manufacturer:

SICHUAN XINCHENG BIOLOGICAL CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 28, 2021

SICHUAN XINCHENG NT-proBNP Assay Kit by Immunofluorescence Chromatography Method

Manufacturer:

SICHUAN XINCHENG BIOLOGICAL CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 25, 2021

SICHUAN XINCHENG Troponin I Assay Kit by Immunofluorescence Chromatography Method

Manufacturer:

SICHUAN XINCHENG BIOLOGICAL CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 15, 2021

SICHUAN XINCHENG Interleukin-6 Assay Kit by Immunofluorescence Chromatography Method

Manufacturer:

SICHUAN XINCHENG BIOLOGICAL CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 13, 2021

SICHUAN XINCHENG Hemoglobin A1c Assay Kit by Immunofluorescence Chromatography Method

Manufacturer:

SICHUAN XINCHENG BIOLOGICAL CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 8, 2021

VivaDiag™ C-Reactive Protein Control Solution

Manufacturer:

VIVACHEK BIOTECH (HANGZHOU) CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 8, 2021

SICHUAN XINCHENG D-Dimer Assay Kit by Immunofluorescence Chromatography Method

Manufacturer:

SICHUAN XINCHENG BIOLOGICAL CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 4, 2021

CITEST Multi-Drug 6 Drugs Rapid Test Cup (Oral Fluid) (OPI/MET/COC/AMP/BZO/THC )

Manufacturer:

HANGZHOU ALLTEST BIOTECH CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 18, 2021

VivaDiag™ POCT Analyzer and Accessories

Manufacturer:

VIVACHEK BIOTECH (HANGZHOU) CO., LTD. CHINA A COMPANY OF VIVACHEK LABORATORIES, INC., USA

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 19, 2021

CITEST Multi Drug 5 Drugs Rapid Test 1-Step Cup (Urine) (AMP, COC,MET,MOP,THC)

Manufacturer:

HANGZHOU ALLTEST BIOTECH CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 26, 2020

CITEST™ LF Reader

Manufacturer:

HANGZHOU ALLTEST BIOTECH CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 26, 2020

BALIO Control Tri Level (L,N,H) OX560/580

Manufacturer:

R&D SYSTEMS, INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 26, 2020

CITEST™ Urinalysis Reagent Strips – 12U (Urine) (LEU/NIT/URO/PRO/pH/BLO/SG/KET/BIL/GLU/ASC/ALB)

Manufacturer:

HANGZHOU ALLTEST BIOTECH CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 22, 2020

BALIO Control Tri Level (L,N,H) OX360

Manufacturer:

R&D SYSTEMS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 17, 2020

INTHERMA VACUUM EDTA (K3) (Glass Tube)

Manufacturer:

WEIHAI HONGYU MEDICAL DEVICES CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 1, 2020

VALUE Normal Control OX560/580

Manufacturer:

R&D SYSTEMS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 29, 2020

CITEST Multi Drug 5 Drugs Rapid Test Cassette (AMP/COC/MET/MOP/THC)

Manufacturer:

HANGZHOU ALLTEST BIOTECH CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 28, 2020

CITEST Multi Drug 3 Drugs Rapid Test Cassette (AMP/THC/COC)

Manufacturer:

HANGZHOU ALLTEST BIOTECH CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 24, 2020

BALIO Calibrator Plus

Manufacturer:

R&D SYSTEMS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 22, 2020

I.S.E Pathological Control Serum

Manufacturer:

I.S.E S.R.L.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 23, 2020

Data sourced from BPOM (Badan Pengawas Obat dan Makanan), Indonesia.

Last updated: December 2025