DS Syphilis One Step Rapid Test - Indonesia BPOM Medical Device Registration

DS Syphilis One Step Rapid Test is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20303717575. The device is manufactured by ZHEJIANG ORIENT GENE BIOTECH CO, LTD. from China, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is BINABAKTI NIAGAPERKASA.

This page provides comprehensive regulatory information including complete registration details, manufacturer information, authorized representative details, product classification, and related products. Pure Global AI offers free access to 67,600+ Indonesia medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.

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BPOM Registered

Risk Class Kelas Resiko : C

DS Syphilis One Step Rapid Test

Analysis ID: AKL 20303717575

Risk Classification

Kelas Resiko : C

Product Class

Kelas : 2

Manufacturer

ZHEJIANG ORIENT GENE BIOTECH CO, LTD.

Country of Origin

China

Authorized Representative

BINABAKTI NIAGAPERKASA

AR Address

Jl. Kebon Jeruk I No. 32 Taman Sari Jakarta Barat

Registration Date

Nov 02, 2022

Expiry Date

Aug 26, 2025

Product Type

Serological Reagents

Treponema pallidum nontreponemal test reagents.

Invitro Diagnostics

DJ Fang

MedTech Regulatory Expert

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