ENVITRO HPLC Hemoglobin Analyzer - Indonesia BPOM Medical Device Registration
ENVITRO HPLC Hemoglobin Analyzer is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20205420063. 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. ENVIRO MEDITECH PRIMARY.
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. ENVIRO MEDITECH PRIMARYAR Address
Jl.Tanah Abang II No.67
Registration Date
Mar 31, 2024
Expiry Date
Dec 31, 2026
Product Type
Automatic and Semi-Automatic Hematology Equipment
Automated hemoglobin system.
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
CELITRON Integrated Sterilizer & Shedder (ISS 25L)
CELITRON MEDICAL TECHNOLOGIES KFT
ENVITRO HB 1 HPLC Hemoglobin Reagent Set
AEHEALTH LIMITED
IGENESIS Nucleic Acid and Purification Kit
IGENESIS (SHANGHAI) CO., LTD.
IGENESIS Automated Fully Enclosed qPCR Instrument
IGENESIS (SHANGHAI) CO., LTD.
BIOTRON Human Papillomavirus (HPV) 15 Genotype Detection Kit (Fluorescene PCR Melting Curve Method)
GUANGZHOU BIOTRON TECHNOLOGY CO., LTD.
FOSUN Novel Coronavirus (2019-nCoV) RT-PCR Detection Kit
FOSUN DIAGNOSTICS (SHANGHAI) CO., LTD
TRAINMEDICS Real-Time PCR System
XI'AN TIANLONG SCIENCE AND TECHNOLOGY CO., LTD.
FOSUN Novel Coronavirus (2019-nCoV) RT-PCR Detection Kit
SHANGHAI FOSUN LONG MARCH MEDICAL SCIENCE CO., LTD
CELITRON Integrated Sterilizer and Shredder (ISS 25L)
CELITRON MEDICAL TECHNOLOGIES KFT.
FOSUN Ultrapure Nucleic Acid Extraction and Purification Kit
SHANGHAI FOSUN LONG MARCH MEDICAL SCIENCE CO., LTD