DCA ™ Systems HbA1c Reagent Kit - Indonesia BPOM Medical Device Registration

DCA ™ Systems HbA1c Reagent Kit is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101520043. The device is manufactured by SIEMENS HEALTHCARE DIAGNOSTICS INC. (MISHAWAKA) from United States, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. SIEMENS HEALTHINEERS INDONESIA.

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BPOM Registered

Risk Class Kelas Resiko : B

DCA ™ Systems HbA1c Reagent Kit

Analysis ID: AKL 20101520043

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Manufacturer

SIEMENS HEALTHCARE DIAGNOSTICS INC. (MISHAWAKA)

Country of Origin

United States

Authorized Representative

PT. SIEMENS HEALTHINEERS INDONESIA

AR Address

Perkantoran Hijau Arkadia Tower F, Lantai 18, Jl.Tahi Bonar Simatupang Kav. 88

Registration Date

Jan 08, 2025

Expiry Date

Aug 01, 2029

Product Type

Clinical Chemistry Test System

Hemoglobin A1c test system.

Invitro Diagnostics

DJ Fang

MedTech Regulatory Expert

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