KOFA UREA Reagent Kit - Indonesia BPOM Medical Device Registration
KOFA UREA Reagent Kit is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101221346. The device is manufactured by GUANGZHOU KOFA BIOTECHNOLOGY CO., LTD. from China, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. INDOLAB ARTHA MEDIKA.
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
GUANGZHOU KOFA BIOTECHNOLOGY CO., LTD.Country of Origin
China
Authorized Representative
PT. INDOLAB ARTHA MEDIKAAR Address
Komp Ruko Sunter Paradise Tahap II Blok.A4 No.43. Sunter Agung Podomoro
Registration Date
Aug 26, 2022
Expiry Date
Mar 06, 2027
Product Type
Clinical Chemistry Test System
Urea nitrogen test system (kit & cair)
Invitro Diagnostics
KOFA DBil Reagent Kit
KOFA ALB Reagent Kit
KOFA TP Reagent Kit
KOFA ALT Reagent Kit
KOFA AST Reagent Kit
KOFA TBil Reagent Kit
KOFA HDL-C Reagent Kit
KOFA LDL-C Reagent Kit
KOFA TCHO Reagent Kit
KOFA Cr hvarfefni Kit
HORRON Electrolyte Analyzer H900
SHENZHEN XILAIHENG MEDICAL ELECTRONICS CO., LTD.
FiCA D-Dimer
SURE BIO-TECH (USA) CO., LTD
FiCA 25-OH-VD
SURE BIO-TECH (USA) CO., LTD
FiCA Ferritin
SURE BIO-TECH (USA) CO., LTD
FiCA hsCRP/CRP
SURE BIO-TECH (USA) CO., LTD
FiCA cTnI
SURE BIO-TECH (USA) CO., LTD
ID LAB TG16 Table Top High Speed Centrifuge
CHANGSHA YINGTAI INSTRUMENT CO.,LTD
FiCA – I FIA Analyzer
SURE BIO-TECH (USA) CO., LTD
ID LAB Blood Collection Vacuum Tubes Sodium Citrate (PET)
JIANGSU HUADONG MEDICAL EQUIPMENT INDUSTRY CO, LTD
ID LAB Capillary Blood Collection Tubes EDTA K3
JIANGSU HUADONG MEDICAL EQUIPMENT INDUSTRY CO, LTD