IMMULITE system C-Peptide Control Module - Indonesia BPOM Medical Device Registration
IMMULITE system C-Peptide Control Module is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101221878. The device is manufactured by SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD. from United Kingdom, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is SIEMENS HEALTHINEERS INDONESIA.
This page provides comprehensive regulatory information including complete registration details, manufacturer information, authorized representative details, product classification, and related products. Pure Global AI offers free access to 67,600+ Indonesia medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.
Risk Classification
Product Class
Kelas : 2
Manufacturer
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD.Country of Origin
United Kingdom
Authorized Representative
SIEMENS HEALTHINEERS INDONESIAAR 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
Oct 27, 2022
Expiry Date
Jan 24, 2025
Product Type
Clinical Chemistry Test System
Quality control material (assayed and unassayed) (cair)
Invitro Diagnostics
IMMULITE 2000 Systems GRH Growth Hormone
IMMULITE 2000 Systems Allergen Specific IgE Universal Kit
IMMULITE 2000 IGF-I
IMMULITE 2000 IGFBP-3
IMMULITE/IMMULITE 1000 Gastrin
IMMULITE 3gAllergy™ Specific IgE Negative Control
SIEMENS N/T Protein Control SL/L
IMMULITE 1000 TNFa
IMMULITE 2000 EPO
IMMULITE D-Dimer Control Module
IMMULITE 2000 Substrate Module 2000T
SIEMENS HEALTHCARE DIAGNOSTICS INC.
DIMENSION GGT Flex Reagent Cartridge
SIEMENS HEALTHCARE DIAGNOSTICS INC.
IMMULITE 2000 Systems GRH Growth Hormone
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD.
DIMENSION Clinical Chemistry System Flex Reagent Cartridge PCHE.
SIEMENS HEALTHCARE DIAGNOSTICS INC. (NEWARK)
DIMENSION Creatinine Flex reagent cartridge (CRE2)
SIEMENS HEALTHCARE DIAGNOSTICS INC.
Dimension Automated HDL Cholesterol Flex (AHDL)
SIEMENS HEALTHCARE DIAGNOSTICS INC
Dimension Alkaline Phosphatase Calibrator ( ALPI CAL )
SIEMENS HEALTHCARE DIAGNOSTICS INC
DIMENSION MBI Flex reagent cartridge
SIEMENS HEALTHCARE DIAGNOSTICS INC.
ADVIA Centaur VB12 Diluent Ready Pack
SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)
Dimension Phosphorus Flex (PHOS) reagent cartridge
SIEMENS HEALTHCARE DIAGNOSTICS INC.