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ELECYS Insulin Elecsys and Cobas e Analyzers - Indonesia BPOM Medical Device Registration

ELECYS Insulin Elecsys and Cobas e Analyzers is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101120272. The device is manufactured by ROCHE DIAGNOSTICS, LTD. from Germany, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. ROCHE INDONESIA.

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BPOM Registered
Risk Class Kelas Resiko : B
ELECYS Insulin Elecsys and Cobas e Analyzers
Analysis ID: AKL 20101120272

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

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

Jan 19, 2021

Expiry Date

Nov 12, 2025

Product Type

Clinical Chemistry Test System

Immunoreactive insulin test system (kit & cair)

Invitro Diagnostics

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