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Elecsys Prolactin II Elecsys and cobas e analyzers - Indonesia BPOM Medical Device Registration

Elecsys Prolactin II Elecsys and cobas e analyzers is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101025954. The device is manufactured by ROCHE DIAGNOSTICS (SUZHOU) LTD from China, 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
Elecsys Prolactin II Elecsys and cobas e analyzers
Analysis ID: AKL 20101025954

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

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

Oct 07, 2020

Expiry Date

Jun 18, 2025

Product Type

Clinical Chemistry Test System

Prolactin (lactogen) test system (kit & cair)

Invitro Diagnostics

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DJ Fang

DJ Fang

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