Pure Global

ALERE NT-proBNP for ARCHITECT Reagent Packs - Indonesia BPOM Medical Device Registration

ALERE NT-proBNP for ARCHITECT Reagent Packs is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101025902. The device is manufactured by AXIS-SHIELD DIAGNOSTICS, LTD from United Kingdom, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. ALERE HEALTH.

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 : C
ALERE NT-proBNP for ARCHITECT Reagent Packs
Analysis ID: AKL 20101025902

Risk Classification

Kelas Resiko : C

Product Class

Kelas : 2

Country of Origin

United Kingdom

Authorized Representative

PT. ALERE HEALTH

AR Address

K-Link Tower Lantai 18 Zona D, E, dan F Jl. Gatot Subroto Kav. 59 A RT 001 RW 003 Kel. Kuningan Timur, Kec. Setiabudi, Jakarta Selatan

Registration Date

Dec 27, 2024

Expiry Date

Nov 30, 2027

Product Type

Clinical Chemistry Test System

B-type natriuretic peptide test system (kit & cair)

Invitro Diagnostics

Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing