WONDFO Coagulation Control - Indonesia BPOM Medical Device Registration
WONDFO Coagulation Control is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20208123759. The device is manufactured by GUANGZHOU WONDFO BIOTECH CO., LTD. from China, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. EXXEL MAIN.
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 WONDFO BIOTECH CO., LTD.Country of Origin
China
Authorized Representative
PT. EXXEL MAINAR Address
JALAN RAJAWALI SELATAN.RUKO MULTI GUNA KEMAYORAN BLOK.6N.JAKARTA UTARA
Registration Date
Jan 20, 2025
Expiry Date
Nov 29, 2029
Product Type
Hematological Reagents
Hematology quality control mixture.
Invitro Diagnostics
FINECARE™ FPSA (Free Prostate Specific Antigen) Rapid Quantitative Test
FINECARE™ FIA Meter II Plus SE
FINECARE™ AMH Rapid Quantitative Test
FINECARE™ FSH Rapid Quantitative Test
FINECARE™ Estradiol (E2) Rapid Quantitative Test
FINECARE™ Testosterone Rapid Quantitative Test
FINECARE™ β-hCG Rapid Quantitative Test
FINECARE™ Progesterone Rapid Quantitative Test
FINECARE™ Dengue NS1 Ag Test
FINECARE™ Prolactin Rapid Quantitative Test
WONDFO cTnI/CK-MB/Myo Multi-Control
GUANGZHOU WONDFO BIOTECH CO., LTD
WONDFO T3/T4/TSH Multi-Control
GUANGZHOU WONDFO BIOTECH CO., LTD
ANSWER HCG Urine Test Strip
GUANGZHOU WONDFO BIOTECH CO., LTD
ANSWER HCG Urine Test Cassette
GUANGZHOU WONDFO BIOTECH CO., LTD
WONDFO MAU Control
GUANGZHOU WONDFO BIOTECH CO., LTD
WONDFO CRP Control
GUANGZHOU WONDFO BIOTECH CO., LTD
WONDFO HbA1c Control
GUANGZHOU WONDFO BIOTECH CO., LTD
WONDFO FIA Meter III Plus
GUANGZHOU WONDFO BIOTECH CO., LTD
ANSWER Diagnostic Kit for IgM Antibody to Hepatitis A Virus (Colloidal Gold)
GUANGZHOU WONDFO BIOTECH CO., LTD
ANSWER One Step Malaria HRP2/pLDH (P.f/Pv) Test
GUANGZHOU WONDFO BIOTECH CO., LTD

