Pure Global

ARIA HBsAg Combo Rapid Test - Indonesia BPOM Medical Device Registration

ARIA HBsAg Combo Rapid Test is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 30305127680. The device is manufactured by BEIJING GENESEE BIOTECH INC. from China, and is classified as Risk Class Kelas Resiko : D. The authorized representative in Indonesia is PT. HERMAN MEDTEK DIAGNOSTICS.

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.

Free Database
Powered by Pure Global AI
BPOM Registered
Risk Class Kelas Resiko : D
ARIA HBsAg Combo Rapid Test
Analysis ID: AKL 30305127680

Risk Classification

Kelas Resiko : D

Product Class

Kelas : 3

Country of Origin

China

Authorized Representative

PT. HERMAN MEDTEK DIAGNOSTICS

AR Address

Jl. Lingkar Luar Barat, Puri Kembangan, Komplek Rukan Puri Mansion Blok A No.16 Kel.Kembangan Selatan Kec.Kembangan, Kota Jakarta Barat, DKI Jakarta

Registration Date

Oct 26, 2021

Expiry Date

Jun 04, 2025

Product Type

Immunological Test System

Antinuclear antibody immunological test system.

Invitro Diagnostics

Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing