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mLabs® D-Dimer - Indonesia BPOM Medical Device Registration

mLabs® D-Dimer is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20207025931. The device is manufactured by MICROPOINT BIOTECHNOLOGIES CO., LTD. from China, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. UBC 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 : C
mLabs® D-Dimer
Analysis ID: AKL 20207025931

Risk Classification

Kelas Resiko : C

Product Class

Kelas : 2

Country of Origin

China

Authorized Representative

PT. UBC MEDICAL INDONESIA

AR Address

Jalan Rawa Gelam V, Blok L Kav. 11-13, Kawasan Industri Pulogadung Jakarta Timur13930

Registration Date

Oct 09, 2020

Expiry Date

Apr 07, 2025

Product Type

Haematology Package and Kit

Fibrinogen/fibrin degradation products assay.

Invitro Diagnostics

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DJ Fang

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