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FiCA D-Dimer - Indonesia BPOM Medical Device Registration

FiCA D-Dimer is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20207520010. The device is manufactured by SURE BIO-TECH (USA) CO., LTD from United States, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. INDOLAB ARTHA MEDIKA.

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 : C
FiCA D-Dimer
Analysis ID: AKL 20207520010

Risk Classification

Kelas Resiko : C

Product Class

Kelas : 2

Country of Origin

United States

Authorized Representative

PT. INDOLAB ARTHA MEDIKA

AR Address

Komp Ruko Sunter Paradise Tahap II Blok.A4 No.43. Sunter Agung Podomoro

Registration Date

Jan 24, 2025

Expiry Date

Jan 30, 2029

Product Type

Haematology Package and Kit

Fibrinogen/fibrin degradation products assay.

Invitro Diagnostics

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