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HEMOCUE HbA1c 501 Test Cartridge - Indonesia BPOM Medical Device Registration

HEMOCUE HbA1c 501 Test Cartridge is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101220285. The device is manufactured by OSANG HEALTHCARE CO., LTD. from Korea, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. ITAMA RANORAYA.

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
HEMOCUE HbA1c 501 Test Cartridge
Analysis ID: AKL 20101220285

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Country of Origin

Korea

Authorized Representative

PT. ITAMA RANORAYA

AR Address

JL. OTTO ISKANDARDINATA RAYA NO. 390, GEDUNG MT. HARYONO SQUARE LANTAI 1 UNIT 1, Desa/Kelurahan Bidara Cina, Kec. Jatinegara, Kota Adm. Jakarta Timur, Provinsi DKI Jakarta, Kode Pos: 13330

Registration Date

Aug 28, 2023

Expiry Date

Jul 11, 2026

Product Type

Clinical Chemistry Test System

Hemoglobin A1c test system.

Invitro Diagnostics

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