Pure Global

ARCHITECT HBeAg Controls - Indonesia BPOM Medical Device Registration

ARCHITECT HBeAg Controls is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20305501977. The device is manufactured by ABBOTT GMBH from Germany, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. ABBOTT PRODUCTS INDONESIA.

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 : B
ARCHITECT HBeAg Controls
Analysis ID: AKL 20305501977

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Manufacturer

ABBOTT GMBH

Country of Origin

Germany

Authorized Representative

PT. ABBOTT PRODUCTS INDONESIA

AR Address

WISMA PONDOK INDAH 2 SUITE 1000, JL. SULTAN ISKANDAR MUDA KAV. V-TA

Registration Date

Oct 29, 2021

Expiry Date

Aug 16, 2026

Product Type

Immunological Test System

Antimitochondrial antibody immunological test system.

Invitro Diagnostics

Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing