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VIDAS HBsAg Ultra (HBS) - Indonesia BPOM Medical Device Registration

VIDAS HBsAg Ultra (HBS) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 30305025968. The device is manufactured by BIOMERIEUX S.A. from France, and is classified as Risk Class Kelas Resiko : D. 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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BPOM Registered
Risk Class Kelas Resiko : D
VIDAS HBsAg Ultra (HBS)
Analysis ID: AKL 30305025968

Risk Classification

Kelas Resiko : D

Product Class

Kelas : 3

Manufacturer

BIOMERIEUX S.A.

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

Nov 06, 2024

Expiry Date

Dec 31, 2028

Product Type

Immunological Test System

Antimitochondrial antibody immunological test system.

Invitro Diagnostics

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