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ACRO HbA1c Rapid Test Cassette (Whole Blood) - Indonesia BPOM Medical Device Registration

ACRO HbA1c Rapid Test Cassette (Whole Blood) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20207420024. The device is manufactured by ACRO BIOTECH INC. from United States, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. RAFA TOPAZ MAIN.

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
ACRO HbA1c Rapid Test Cassette (Whole Blood)
Analysis ID: AKL 20207420024

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Manufacturer

ACRO BIOTECH INC.

Country of Origin

United States

Authorized Representative

PT. RAFA TOPAZ MAIN

AR Address

Taman Buaran Indah I Blok U No. 242 Jl. Radin Inten II, Klender, Jakarta Timur

Registration Date

Mar 19, 2024

Expiry Date

Aug 20, 2026

Product Type

Haematology Package and Kit

Glycosylated hemoglobin assay.

Invitro Diagnostics

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