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m-PIMA™ Analyser and Accessories - Indonesia BPOM Medical Device Registration

m-PIMA™ Analyser and Accessories is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20305028165. The device is manufactured by ABBOTT RAPID DIAGNOSTICS JENA GMBH. from Germany, and is classified as Risk Class Kelas Resiko : B. 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.

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BPOM Registered
Risk Class Kelas Resiko : B
m-PIMA™ Analyser and Accessories
Analysis ID: AKL 20305028165

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Country of Origin

Germany

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

Jul 07, 2022

Expiry Date

Jul 06, 2025

Product Type

Immunological Test System

Multiple autoantibodies immunological test system.

Invitro Diagnostics

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