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COBAS Elecsys Anti-HCV II cobas e analyzers - Indonesia BPOM Medical Device Registration

COBAS Elecsys Anti-HCV II cobas e analyzers is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 30305320698. The device is manufactured by ROCHE DIAGNOSTICS GMBH from Germany, and is classified as Risk Class Kelas Resiko : D. The authorized representative in Indonesia is PT. ROCHE 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
COBAS Elecsys Anti-HCV II cobas e analyzers
Analysis ID: AKL 30305320698

Risk Classification

Kelas Resiko : D

Product Class

Kelas : 3

Country of Origin

Germany

Authorized Representative

PT. ROCHE INDONESIA

AR Address

Gedung AIA Central Lantai 36 Jl. Jend. Sudirman KAV. 48A RT/RW 003/004 Kelurahan Karet Semanggi

Registration Date

Feb 08, 2023

Expiry Date

Aug 30, 2027

Product Type

Immunological Test System

Antinuclear antibody immunological test system.

Invitro Diagnostics

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