Pure Global

FUJIREBIO Tumor Marker Control - Indonesia BPOM Medical Device Registration

FUJIREBIO Tumor Marker Control is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20306320296. The device is manufactured by FUJIREBIO DIAGNOSTICS AB from Sweden, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. EMERALINDO ASIA PACIFIC.

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
FUJIREBIO Tumor Marker Control
Analysis ID: AKL 20306320296

Risk Classification

Kelas Resiko : C

Product Class

Kelas : 2

Country of Origin

Sweden

Authorized Representative

PT. EMERALINDO ASIA PACIFIC

AR Address

RUKAN PERMATA SENAYAN BLOK G15, Lantai 1, JL.TENTARA PELAJAR NO. 5, Desa/Kelurahan Grogol Utara, Kec. Kebayoran Lama, Kota Adm. Jakarta Selatan, Provinsi DKI Jakarta Kode Pos: 12210

Registration Date

Sep 21, 2023

Expiry Date

Feb 24, 2028

Product Type

Tumor Antigen Immunologic Test System

Tumor-associated antigen immunological test system.

Invitro Diagnostics

Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing