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LIVES AFP - Indonesia BPOM Medical Device Registration

LIVES AFP is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20306805412. The device is manufactured by BIOMERIEUX SA. from France, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. ENSEVAL MEDIKA PRIMA.

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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Risk Class Kelas Resiko : B
LIVES AFP

VIDAS AFP

Analysis ID: AKL 20306805412

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Manufacturer

BIOMERIEUX SA.

Country of Origin

France

Authorized Representative

PT. ENSEVAL MEDIKA PRIMA

AR Address

JL. PULO LENTUT NO.12, LT.1 UNIT 1C & LT.2 UNIT 2A, KAWASAN INDUSTRI PULOGADUNG

Registration Date

Jun 13, 2024

Expiry Date

Dec 31, 2028

Product Type

Tumor Antigen Immunologic Test System

AFP-L3% immunological test system.

Invitro Diagnostics

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