IMMULITE Total IgE Control Module - Indonesia BPOM Medical Device Registration
IMMULITE Total IgE Control Module is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20305420577. 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 LTDCountry of Origin
United Kingdom
Authorized Representative
SIEMENS HEALTHINEERS INDONESIAAR Address
Perkantoran Hijau Arkadia Tower F, Lantai 18, Jl.Tahi Bonar Simatupang Kav. 88
Registration Date
Nov 19, 2024
Expiry Date
Jun 25, 2029
Product Type
Immunological Test System
Immunoglobulins A, G, M, D, and E immunological test system.
Invitro Diagnostics
IMMULITE 2000 3gAllergy Specific IgE Positive Control for D1 &D2
IMMULITE 1000 Toxoplasma IgM
IMMULITE 1000 Systems CMV IgG
IMMULITE 2000 Total IgE
IMMULITE 1000 Systems Herpes I & II IgG
IMMULITE IGF-1 Control Module
IMMULITE1000 Rubella IgG
IMMULITE EPO CONTROL MODULE
IMMULITE 2000 3g Allergy Specific IgE Sample Diluent
IMMULITE 2000 D -DIMER
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.