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MINDRAY Anti-HCV Antibody to Hepatitis C Virus (CLIA) - Indonesia BPOM Medical Device Registration

MINDRAY Anti-HCV Antibody to Hepatitis C Virus (CLIA) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 30305915604. The device is manufactured by SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. from China, and is classified as Risk Class Kelas Resiko : D. The authorized representative in Indonesia is PT. MINDRAY MEDICAL 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 : D
MINDRAY Anti-HCV Antibody to Hepatitis C Virus (CLIA)
Analysis ID: AKL 30305915604

Risk Classification

Kelas Resiko : D

Product Class

Kelas : 3

Country of Origin

China

Authorized Representative

PT. MINDRAY MEDICAL INDONESIA

AR Address

Menara DEA II Lt.17, Jl. Mega Kuningan Barat Kav.E4.3 No.1-2, Kel. Kuningan Timur, Kec.Setiabudi Kawasan Mega Kuningan, Jakarta Selatan

Registration Date

Oct 23, 2024

Expiry Date

Jun 29, 2025

Product Type

Immunological Test System

Antinuclear antibody immunological test system.

Invitro Diagnostics

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