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ONE STEP Cassette Style Anti HIV 1+2 Rapid Screen Test (Whole Blood) - Indonesia BPOM Medical Device Registration

ONE STEP Cassette Style Anti HIV 1+2 Rapid Screen Test (Whole Blood) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 30305220581. The device is manufactured by NANTONG EGENS BIOTECHNOLOGY CO., LTD. from China, and is classified as Risk Class Kelas Resiko : D. The authorized representative in Indonesia is PT. DANPAC PHARMA.

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
ONE STEP Cassette Style Anti HIV 1+2 Rapid Screen Test (Whole Blood)
Analysis ID: AKL 30305220581

Risk Classification

Kelas Resiko : D

Product Class

Kelas : 3

Country of Origin

China

Authorized Representative

PT. DANPAC PHARMA

AR Address

Plaza Asia, Lt. 6D, Kav. 59, RT 005/RW 003

Registration Date

Dec 06, 2022

Expiry Date

Nov 30, 2027

Product Type

Immunological Test System

Multiple autoantibodies immunological test system.

Invitro Diagnostics

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