SERENITY Dengue NS1 Antigen Test - Indonesia BPOM Medical Device Registration

SERENITY Dengue NS1 Antigen Test is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20303611163. The device is manufactured by CORE TECHNOLOGY CO., LTD from China, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. SERENITY INDONESIA.

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BPOM Registered

Risk Class Kelas Resiko : B

SERENITY Dengue NS1 Antigen Test

Analysis ID: AKL 20303611163

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Manufacturer

CORE TECHNOLOGY CO., LTD

Country of Origin

China

Authorized Representative

PT. SERENITY INDONESIA

AR Address

Komplek Ruko Permata Kota Blok Q No. 10 Jl. Pangeran Tubagus Angke No.170 RT.010 RW . 01

Registration Date

Jun 09, 2023

Expiry Date

Feb 07, 2028

Product Type

Serological Reagents

Plasmodium species antigen detection assays

Invitro Diagnostics

DJ Fang

MedTech Regulatory Expert

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Other Products from CORE TECHNOLOGY CO., LTD

Products from the same manufacturer (2 products)

CORETESTS Multi- Drug Test Cup CK 7P (AMP/MET/THC/BZO/MOP/SOMA/COC)

Kelas Resiko : C

CORETESTS Multi- Drug Test Cup CK 10P (AMP/SOMA/BZO/COC/MET/MDMA/MTD/MOP/PCP/THC)

Kelas Resiko : C

Other Products from PT. SERENITY INDONESIA

Products with the same authorized representative (10 products)

SERENITY Walking Stick

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Kelas Resiko : A

SERENITY Commode

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Kelas Resiko : A

SERENITY Walking Stick

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Kelas Resiko : A

SERENITY Commode

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Kelas Resiko : A

SERENITY Walking Stick

FOSHAN DONGFANG MEDICAL EQUIPMENT MANUFACTORY LTD.

Kelas Resiko : A

SERENITY Walking Stick

FOSHAN DONGFANG MEDICAL EQUIPMENT MANUFACTORY LTD.

Kelas Resiko : A

SERENITY Walking Aid

FOSHAN DONGFANG MEDICAL EQUIPMENT MANUFACTORY LTD.

Kelas Resiko : A

SERENITY Walking Aid Rollator

FOSHAN DONGFANG MEDICAL EQUIPMENT MANUFACTORY LTD.

Kelas Resiko : A

SERENITY Commode

FOSHAN DONGFANG MEDICAL EQUIPMENT MANUFACTORY LTD.

Kelas Resiko : A

SERENITY Walking Stick

FOSHAN DONGFANG MEDICAL EQUIPMENT MANUFACTORY LTD.

Kelas Resiko : A