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COBAS CalSet Anti-SARS-CoV-2 S cobas e analyzers - Indonesia BPOM Medical Device Registration

COBAS CalSet Anti-SARS-CoV-2 S cobas e analyzers is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20303027486. The device is manufactured by ROCHE DIAGNOSTICS GMBH from Germany, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is 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 : B
COBAS CalSet Anti-SARS-CoV-2 S cobas e analyzers
Analysis ID: AKL 20303027486

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Country of Origin

Germany

Authorized Representative

ROCHE INDONESIA

AR Address

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

Registration Date

Aug 13, 2021

Expiry Date

Sep 23, 2025

Product Type

Serological Reagents

Respiratory viral panel multiplex nucleic acid assay

Invitro Diagnostics

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