ADVIA Chemistry Special Chemistry Calibrator (SPCL CHEM CAL ) - Indonesia BPOM Medical Device Registration
ADVIA Chemistry Special Chemistry Calibrator (SPCL CHEM CAL ) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101220260. The device is manufactured by RANDOX LABORATORIES 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
RANDOX LABORATORIES LTDCountry 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
Mar 08, 2022
Expiry Date
Mar 04, 2025
Product Type
Clinical Chemistry Test System
Calibrator (cair)
Invitro Diagnostics
RANDOX RX series EtOH (ETHANOL)
RANDOX RX series TIBC_2 (Total Iron-Binding Capacity 2)
RANDOX RX series ASO 2 (ANTI-STREPTOLYSIN-O 2)
RANDOX RX series Iron (Fe)
RANDOX RX series LAC (L - Lactate)
RANDOX RX series IgM (Immunoglobulin M)
RANDOX RX series Ca (Calcium)
RANDOX RX series IgG (Immunoglobulin G)
RANDOX RX series IgE (Immunoglobulin E)
RANDOX RX series Fe (Iron)
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.