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POINTE Hemoglobin A1c Control Set - Indonesia BPOM Medical Device Registration

POINTE Hemoglobin A1c Control Set is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101420763. The device is manufactured by HORIBA INSTRUMENTS INCORPORATED from United States, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. HORIBA 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 : B
POINTE Hemoglobin A1c Control Set
Analysis ID: AKL 20101420763

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Country of Origin

United States

Authorized Representative

PT. HORIBA INDONESIA

AR Address

Jl. Jalur Sutera , Blok. 20A, No. 16 - 17, Kel. Kunciran, Kec. Pinang

Registration Date

Apr 22, 2024

Expiry Date

Jan 01, 2029

Product Type

Clinical Chemistry Test System

Quality control material (assayed and unassayed) (cair)

Invitro Diagnostics

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