MONO X Fluorescence Immunoassay Analyzer (Immunofluorescence Chromatography) - Indonesia BPOM Medical Device Registration
MONO X Fluorescence Immunoassay Analyzer (Immunofluorescence Chromatography) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20304320137. The device is manufactured by AEHEALTH LIMITED from United Kingdom, 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
AEHEALTH LIMITEDCountry of Origin
United Kingdom
Authorized Representative
PT. BINTANG MONO INDONESIAAR Address
TAMAN TEKNO BSD SEKTOR XI BLOK J 3 NOMOR 25
Registration Date
Dec 04, 2023
Expiry Date
Feb 03, 2026
Product Type
Immunology Laboratory Equipment and Reagents
Immunofluorometer equipment
Invitro Diagnostics
FOKUS FDI HM-3 Plus Diluent Hematology Reagent
FOKUS Auto 3-Diff Hematology Analyzer
FOKUS FDI HM-5 Plus DIFF Lyse Hematology Reagent
FOKUS FDI HM-5 Plus Diluent Hematology Reagent
BM Diagnostics BM-C-5 LH Lyse Hematology Reagent
BM Diagnostics BM-C-5 Diluent Hematology Reagent
BM Diagnostics BM-C-5 Hematology Analyzer Cell Cleanser
BM Diagnostics BM-C-5 Diff Lyse Hematology Reagent
FOKUS FDI HM-5Plus LH lyse hematology reagent
BM Diagnostics BM-C-3 Lyse Hematology Reagent
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.