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Cobas PCR Urine Sample Kit - Indonesia BPOM Medical Device Registration

Cobas PCR Urine Sample Kit is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 10203320235. The device is manufactured by ROCHE DIAGNOSTICS (SUZHOU) LTD from China, and is classified as Risk Class Kelas Resiko : A. 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 : A
Cobas PCR Urine Sample Kit
Analysis ID: AKL 10203320235

Risk Classification

Kelas Resiko : A

Product Class

Kelas : 1

Country of Origin

China

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

Jun 30, 2023

Expiry Date

Apr 05, 2028

Product Type

Pathology Equipment and Accessories

Specimen transport and storage container.

Invitro Diagnostics

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DJ Fang

DJ Fang

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