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FORTACEdx Albumin - Indonesia BPOM Medical Device Registration

FORTACEdx Albumin is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101323073. The device is manufactured by LINEAR CHEMICALS, S.L.U from Spain, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. FORTACE DIAGNOSTICS 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
FORTACEdx Albumin
Analysis ID: AKL 20101323073

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Country of Origin

Spain

Authorized Representative

PT. FORTACE DIAGNOSTICS INDONESIA

AR Address

FORTACE DIAGNOSTICS INDONESIA

Registration Date

Jul 11, 2023

Expiry Date

May 26, 2026

Product Type

Clinical Chemistry Test System

Albumin test system (kit & cair)

Invitro Diagnostics

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