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PRECHEK Hepatitis B Virus Antigen Detected in Whole Blood (HbsAg) - Indonesia BPOM Medical Device Registration

PRECHEK Hepatitis B Virus Antigen Detected in Whole Blood (HbsAg) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 30305913609. The device is manufactured by ATLAS LINK TECHNOLOGY CO., LTD. from China, and is classified as Risk Class Kelas Resiko : D. The authorized representative in Indonesia is PT. DEMKA SAKTI.

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 : D
PRECHEK Hepatitis B Virus Antigen Detected in Whole Blood (HbsAg)
Analysis ID: AKL 30305913609

Risk Classification

Kelas Resiko : D

Product Class

Kelas : 3

Country of Origin

China

Authorized Representative

PT. DEMKA SAKTI

AR Address

Jl. Tanah Abang III No. 19 A - B, Jakarta Pusat

Registration Date

Jun 14, 2019

Expiry Date

Nov 10, 2023

Product Type

Immunological Test System

Antimitochondrial antibody immunological test system.

Invitro Diagnostics

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