FINECARE™ LH Rapid Quantitative Test - Indonesia BPOM Medical Device Registration
FINECARE™ LH Rapid Quantitative Test is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101422493. 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. CIPTA VARIA KHARISMA UTAMA.
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. CIPTA VARIA KHARISMA UTAMAAR Address
Jl. Utan Kayu Raya No. 105A Jakarta
Registration Date
Dec 05, 2024
Expiry Date
May 22, 2029
Product Type
Clinical Chemistry Test System
Luteinizing hormone test system (card)
Invitro Diagnostics
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FINECARE™ FPSA (Free Prostate Specific Antigen) Rapid Quantitative Test
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FINECARE™ FIA Meter II Plus SE
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FINECARE™ FSH Rapid Quantitative Test
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FINECARE™ AMH Rapid Quantitative Test
GUANGZHOU WONDFO BIOTECH CO., LTD.
FINECARE™ Estradiol (E2) Rapid Quantitative Test
GUANGZHOU WONDFO BIOTECH CO., LTD.
FINECARE™ Testosterone Rapid Quantitative Test
GUANGZHOU WONDFO BIOTECH CO., LTD.
FINECARE™ β-hCG Rapid Quantitative Test
GUANGZHOU WONDFO BIOTECH CO., LTD.
FINECARE™ Progesterone Rapid Quantitative Test
GUANGZHOU WONDFO BIOTECH CO., LTD.
FINECARE™ Dengue NS1 Ag Test
GUANGZHOU WONDFO BIOTECH CO., LTD.
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