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FORTACEdx HDL-Cholesterol Direct - Indonesia BPOM Medical Device Registration

FORTACEdx HDL-Cholesterol Direct is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101323072. 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 HDL-Cholesterol Direct
Analysis ID: AKL 20101323072

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

May 20, 2023

Expiry Date

May 15, 2026

Product Type

Clinical Chemistry Test System

Lipoprotein test system (kit & cair)

Invitro Diagnostics

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