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Abionic IVD Capsule D-Dimer - Indonesia BPOM Medical Device Registration

Abionic IVD Capsule D-Dimer is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20207320437. The device is manufactured by ABIONIC Ltd from Switzerland, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. TRANSMEDIC 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
Abionic IVD Capsule D-Dimer
Analysis ID: AKL 20207320437

Risk Classification

Kelas Resiko : C

Product Class

Kelas : 2

Manufacturer

ABIONIC Ltd

Country of Origin

Switzerland

Authorized Representative

PT. TRANSMEDIC INDONESIA

AR Address

PERKANTORAN MENARA ERA UNIT G-01, JL. SENEN RAYA NO. 135-137

Registration Date

Nov 08, 2023

Expiry Date

Feb 08, 2027

Product Type

Haematology Package and Kit

Fibrinogen/fibrin degradation products assay.

Invitro Diagnostics

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