SCLAVO Total Bilirubin - Indonesia BPOM Medical Device Registration
SCLAVO Total Bilirubin is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101213345. The device is manufactured by SCLAVO DIAGNOSTICS INTERNATIONAL S.p.A from Italy, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. BUANA MITRA SUKSES.
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
SCLAVO DIAGNOSTICS INTERNATIONAL S.p.ACountry of Origin
Italy
Authorized Representative
PT. BUANA MITRA SUKSESAR Address
RUKO NIAGA KALIMAS I BLOK B 10-11 JL INSPEKSI KALIMALANG
Registration Date
Sep 27, 2024
Expiry Date
Feb 22, 2029
Product Type
Clinical Chemistry Test System
Bilirubin (total or direct) test system (kit & cair)
Invitro Diagnostics
ATLAS Rheumatoid Factor (RF) Latex Kit
ATLAS MEDICAL
ATLAS Salmonella OB Reagent
ATLAS MEDICAL.
ATLAS Salmonella OD Reagent
ATLAS MEDICAL.
ATLAS Anti-A Monoclonal Reagent
ATLAS MEDICAL
ATLAS Anti-D IgG/IgM Blend Reagent
ATLAS MEDICAL
ATLAS Salmonella HA Reagent
ATLAS MEDICAL.
BM Diagnostics BM-3D Lyse for BM-H3900S Hematology Analyzer
DIRUI INDUSTRIAL CO., LTD., P.R.
QUALITY ACCESS Tuberculosis Test Cassette (Whole Blood/Serum/Plasma)
ATLAS MEDICAL
ATLAS ASO Latex Kit
ATLAS MEDICAL.
BM Diagnostics BM Probe Cleanser for BM-H3900S Hematology Analyzer
DIRUI INDUSTRIAL CO., LTD., P.R.