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INNOTEST hTau Ag - Indonesia BPOM Medical Device Registration

INNOTEST hTau Ag is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101914862. The device is manufactured by FUJIREBIO EUROPE N.V. from Belgium, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. ANDAMAN MEDICAL 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.

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BPOM Registered
Risk Class Kelas Resiko : B
INNOTEST hTau Ag
Analysis ID: AKL 20101914862

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Country of Origin

Belgium

Authorized Representative

PT. ANDAMAN MEDICAL INDONESIA

AR Address

Menara Cardig Lantai 1, Jalan Raya Halim Perdanakusuma

Registration Date

Jan 11, 2024

Expiry Date

Mar 21, 2028

Product Type

Clinical Chemistry Test System

Total protein test system (kit & cair)

Invitro Diagnostics

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