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IMMULITE D-Dimer Control Module - Indonesia BPOM Medical Device Registration

IMMULITE D-Dimer Control Module is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20207320301. The device is manufactured by SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD. from United Kingdom, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. SIEMENS HEALTHINEERS INDONESIA.

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BPOM Registered
Risk Class Kelas Resiko : C
IMMULITE D-Dimer Control Module
Analysis ID: AKL 20207320301

Risk Classification

Kelas Resiko : C

Product Class

Kelas : 2

Country of Origin

United Kingdom

Authorized Representative

PT. SIEMENS HEALTHINEERS INDONESIA

AR Address

Perkantoran Hijau Arkadia Tower F, Lantai 18, Jl. Tahi Bonar Simatupang Kav. 88, Kel. Kebagusan, Kec. Pasar Minggu, Jakarta Selatan, DKI Jakarta

Registration Date

May 16, 2023

Expiry Date

Jan 24, 2025

Product Type

Haematology Package and Kit

Fibrinogen/fibrin degradation products assay.

Invitro Diagnostics

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