IMMULITE 1000 Systems TES Total Testosterone - Indonesia BPOM Medical Device Registration
IMMULITE 1000 Systems TES Total Testosterone is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101120282. 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 PT. 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
PT. 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
Jan 16, 2021
Expiry Date
Jan 24, 2025
Product Type
Clinical Chemistry Test System
Testosterone test system (kit & 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
ADVIA Centaur Calibrator D
SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)
DIMENSION Revised C-Reactive Protein Calibrator (RCRP CAL)
SIEMENS HEALTHCARE DIAGNOSTICS INC.
IMMULITE 2000 Systems Allergen Specific IgE Universal Kit
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD.
IMMULITE 2000 3gAllergy Specific IgE Positive Control for D1 &D2
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
ADVIA Centaur Anti-HBs2 Quality Control (aHBs2 QC)
SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)
DIMENSION Bilirubin Calibrator (TBI/DBI CAL)
SIEMENS HEALTHCARE DIAGNOSTICS INC.
ADVIA Centaur CA 15-3
SIEMENS HEALTHCARE DIAGNOSTICS INC. (WALPOLE)
ADVIA Centaur Insulin (IRI)
MINARIS MEDICAL CO., LTD.
CLINITEK Status+ Analyzer and Accessories
SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LTD.
DIMENSION Tacrolimus Calibrator
SIEMENS HEALTHCARE DIAGNOSTICS INC.