MONOTES T4 (Total Thyroxine) Rapid Quantitative Test (Immunofluorescence Assay) and Accessories - Indonesia BPOM Medical Device Registration
MONOTES T4 (Total Thyroxine) Rapid Quantitative Test (Immunofluorescence Assay) and Accessories is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101323987. The device is manufactured by XIAMEN BIOTIME BIOTECHNOLOGY CO., LTD from China, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. BINTANG MONO 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
XIAMEN BIOTIME BIOTECHNOLOGY CO., LTDCountry of Origin
China
Authorized Representative
PT. BINTANG MONO INDONESIAAR Address
Perum Mahkota Simprug Blok A13 No. 9
Registration Date
Oct 04, 2023
Expiry Date
Apr 17, 2026
Product Type
Clinical Chemistry Test System
Total thyroxine test system (card)
Invitro Diagnostics
MONOTES FIA Analyzer BIOT-YG-I and Accesories
MONOTES TSH (Thyroid Stimulating Hormone) Rapid Quantitative Test (Immunofluorescence Assay) and Accessories
MONOTES HbA1c (Glycated Hemoglobin) Rapid Quantitative Test (Immunofluorescence Assay) and Accessories
MONOTES D-Dimer Rapid Quantitative Test (Immunofluorescence Assay) and Accessories
MONOTES Micro Blood Collection Tubes EDTA K3 PET Tube
JIANGSU RONGYE TECHNOLOGY CO., LTD.
MONOTES Sterile Lancet Twisted Type
JIANGSU RONGYE TECHNOLOGY CO.,LTD.
LYSUN BHM-102 Hemoglobin Analysis Meter
HANGZHOU LYSUN BIOTECHNOLOGY CO., LTD.
MONOTES Vacuum Tube Glucose Glass Tube
JIANGSU RONGYE TECHNOLOGY CO.,LTD.
MONOTES Vacuum Tube EDTA K3 Glass Tube
JIANGSU RONGYE TECHNOLOGY CO, LTD.
MONOTES FIA Analyzer BIOT-YG-I and Accesories
XIAMEN BIOTIME BIOTECHNOLOGY CO., LTD
MONOTES Vacuum Tube Glucose PET Tube
JIANGSU RONGYE TECHNOLOGY CO.,LTD.
MONOTES Vacuum Tube ESR Sodium Sitrate/4NC PET Tube
JIANGSU RONGYE TECHNOLOGY CO.,LTD.
MONOTES Vacuum Tube Glass Plain (No Additive)
JIANGSU RONGYE TECHNOLOGY CO.,LTD.
MONOTES Vacuum Tube EDTA K3 PET Tube
JIANGSU RONGYE TECHNOLOGY CO.,LTD.