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HEMONART CompactOne 9 ACT Analyzer - Indonesia BPOM Medical Device Registration

HEMONART CompactOne 9 ACT Analyzer is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20207320485. The device is manufactured by HEMONART MEDICAL SYSTEMS INDUSTRY TRADE JOINT STOCK COMPANY from Turkey, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. BINTANG MONO 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
HEMONART CompactOne 9 ACT Analyzer
Analysis ID: AKL 20207320485

Risk Classification

Kelas Resiko : C

Product Class

Kelas : 2

Country of Origin

Turkey

Authorized Representative

PT. BINTANG MONO INDONESIA

AR Address

TAMAN TEKNO BSD SEKTOR XI BLOK J 3 NOMOR 25

Registration Date

Dec 22, 2023

Expiry Date

Jan 16, 2028

Product Type

Haematology Package and Kit

Activated whole blood clotting time tests.

Invitro Diagnostics

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