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COBAS 5800 System and Accessories - Indonesia BPOM Medical Device Registration

COBAS 5800 System and Accessories is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20304420021. The device is manufactured by ROCHE DIAGNOSTICS INTERNATIONAL LTD from Switzerland, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. ROCHE INDONESIA.

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BPOM Registered
Risk Class Kelas Resiko : C
COBAS 5800 System and Accessories
Analysis ID: AKL 20304420021

Risk Classification

Kelas Resiko : C

Product Class

Kelas : 2

Country of Origin

Switzerland

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

Mar 05, 2024

Expiry Date

Oct 05, 2026

Product Type

Immunology Laboratory Equipment and Reagents

RNA Preanalytical Systems.

Invitro Diagnostics

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