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ISE Calibrator Direct COBAS INTEGRA - Indonesia BPOM Medical Device Registration

ISE Calibrator Direct COBAS INTEGRA is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101113245. 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 PT. ROCHE INDONESIA.

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BPOM Registered
Risk Class Kelas Resiko : B
ISE Calibrator Direct COBAS INTEGRA
Analysis ID: AKL 20101113245

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

Sep 14, 2020

Expiry Date

Jun 18, 2025

Product Type

Clinical Chemistry Test System

Calibrator (cair)

Invitro Diagnostics

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