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FOKUS DIAGNOSTIC INDONESIA

Authorized Representative in Indonesia

Jl. Jatipadang Raya No.9A, RT.6/RW.4, Kelurahan Jatipadang, Kecamatan Pasar Minggu, Kota Jakarta Selatan, DKI Jakarta 12540
23 Products Represented
14 Manufacturers
Total Products
23
Manufacturers
14
Product Classes
2
Risk Classes
3
Risk Classification Breakdown
Distribution of represented products across risk classes
Kelas Resiko : A
6 products
26.1%
Kelas Resiko : B
13 products
56.5%
Kelas Resiko : C
4 products
17.4%
Manufacturer Portfolio
Products organized by manufacturer
All Represented Products (23)
Complete portfolio registered with BPOM

DxFLEX with Autoloader and Accessories

Manufacturer:

BECKMAN COULTER BIOTECHNOLOGY (SUZHOU) CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 10, 2025

ClearLLab Control Cells Normal

Manufacturer:

DASH, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 6, 2025

ClearLLab Control Cells Abnormal

Manufacturer:

DASH, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 6, 2025

FOCUS Dengue NS1 Antigen Cassette

Manufacturer:

ZEPHYR BIOMEDICALS - A DIV. OF TULIP DIAGNOSTICS (P) LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 24, 2025

FOKUS Febrile Antigen O-B Paratyphi

Manufacturer:

PULSE SCIENTIFIC INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 4, 2025

IOTest 3 Lysing Solution

Manufacturer:

IMMUNOTECH S.A.S., A BECKMAN COULTER COMPANY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 22, 2024

IOTest 3 Fixative Solution

Manufacturer:

IMMUNOTECH S.A.S., A BECKMAN COULTER COMPANY.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 19, 2024

CYTO-STAT tetraCHROME CD45-FITC/CD56-RD1/CD19-ECD/CD3-PC5

Manufacturer:

BECKMAN COULTER, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 12, 2024

UNITED IMAGING Digital Mammography X-ray Imaging System

Manufacturer:

SHANGHAI UNITED IMAGING HEALTHCARE CO,. LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 22, 2024

UNITED IMAGING Medical Linear Accelerator System

Manufacturer:

SHANGHAI UNITED IMAGING HEALTHCARE CO,. LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 29, 2024

XENTA Procalcitonin (PCT) Detection Kit (Fluorescence Immuno chromatography)

Manufacturer:

XENTA BIOMEDICAL SCIENCE CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 3, 2024

CYTO-STAT/COULTER CLONE T8-RD1/T4-FITC

Manufacturer:

BECKMAN COULTER, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 25, 2024

ClearLLab 10C T Cell Tube

Manufacturer:

BECKMAN COULTER INDIA PRIVATE LIMITED.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 15, 2023

AQUIOS IMMUNO-TROL Low Cells

Manufacturer:

BECKMAN COULTER, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 2, 2023

LeukoSure Enumeration Kit

Manufacturer:

BECKMAN COULTER, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 30, 2023

IsoFlow Sheath Fluid

Manufacturer:

BECKMAN COULTER, INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 25, 2023

COULTER CLONE T4 - FITC

Manufacturer:

BECKMAN COULTER, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 25, 2023

AQUIOS Sodium Hypochlorite Solution

Manufacturer:

CLINICAL DIAGNOSTIC SOLUTIONS, INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 7, 2022

FOCUS Tubectomy Set

Manufacturer:

CEATEC MEDIZINTECHNIK GMBH

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jul 7, 2022

FOKUS Urology Basic Instrument Set

Manufacturer:

CEATEC MEDIZINTECHNIK GMBH

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jun 30, 2022

FOKUS Tonsillectomy Set

Manufacturer:

CEATEC MEDIZINTECHNIK GMBH

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jun 21, 2022

FOKUS hCG Strip

Manufacturer:

GENIX TECHNOLOGY INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 19, 2021

AIM Filter

Manufacturer:

GUANGZHOU LEIDE BIOSCIENCES CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 6, 2020

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

Last updated: December 2025