SIEMENS N Latex FLC Kappa - Indonesia BPOM Medical Device Registration
SIEMENS N Latex FLC Kappa is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20305220151. The device is manufactured by SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH from Germany, 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 GMBHCountry of Origin
Germany
Authorized Representative
SIEMENS HEALTHINEERS INDONESIAAR Address
Perkantoran Hijau Arkadia Tower F, Lantai 18, Jl.Tahi Bonar Simatupang Kav. 88
Registration Date
Jan 27, 2024
Expiry Date
Oct 19, 2026
Product Type
Immunological Test System
Immunoglobulin (light chain specific) immunological test system.
Invitro Diagnostics
IMMULITE Probe Wash Module
N Latex ADnase B
SIEMENS N Protein Control LC2
SIEMENS N Antiserum to Human Fibrinogen
SIEMENS N Protein Control LC1
SIEMENS N Sample Diluent
SIEMENS N Antiserum to Human Antithrombin III
SIEMENS N/T N Latex Ferritin
SIEMENS N Antiserum to Human Hemopexin
SIEMENS N Latex IgE mono
DIMENSION Creatinine Flex reagent cartridge (CRE2)
SIEMENS HEALTHCARE DIAGNOSTICS INC.
DIMENSION Clinical Chemistry System Flex Reagent Cartridge PCHE.
SIEMENS HEALTHCARE DIAGNOSTICS INC. (NEWARK)
Dimension Alkaline Phosphatase Calibrator ( ALPI CAL )
SIEMENS HEALTHCARE DIAGNOSTICS INC
IMMULITE 2000 Substrate Module 2000T
SIEMENS HEALTHCARE DIAGNOSTICS INC.
IMMULITE 2000 Systems GRH Growth Hormone
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD.
Dimension Automated HDL Cholesterol Flex (AHDL)
SIEMENS HEALTHCARE DIAGNOSTICS INC
DIMENSION MBI Flex reagent cartridge
SIEMENS HEALTHCARE DIAGNOSTICS INC.
DIMENSION GGT Flex Reagent Cartridge
SIEMENS HEALTHCARE DIAGNOSTICS INC.
ADVIA Centaur VB12 Diluent Ready Pack
SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)
DIMENSION Magnesium Flex (MG)
SIEMENS HEALTHCARE DIAGNOSTICS INC