SOPHONIX Luteinizing Hormone (LH) Test Kit - Indonesia BPOM Medical Device Registration
SOPHONIX Luteinizing Hormone (LH) Test Kit is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101324106. The device is manufactured by SOPHONIX CO.,LTD from China, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. GOLDEN MEDIKA MANDIRI.
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
SOPHONIX CO.,LTDCountry of Origin
China
Authorized Representative
PT. GOLDEN MEDIKA MANDIRIAR Address
Jl. Raya Kalirungkut 27 Blok C-65
Registration Date
Oct 15, 2023
Expiry Date
Mar 10, 2027
Product Type
Clinical Chemistry Test System
Luteinizing hormone test system (kit & cair)
Invitro Diagnostics
BIOTIME CRP Rapid Quantitative Test
XIAMEN BIOTIME BIOTECHNOLOGY CO., LTD.
BIOTIME TSH Rapid Quantitative Test
XIAMEN BIOTIME BIOTECHNOLOGY CO., LTD.
BIOTIME HbA1c Rapid Quantitative Test
XIAMEN BIOTIME BIOTECHNOLOGY CO., LTD.
BIOTIME TT4 Rapid Quantitative Test
XIAMEN BIOTIME BIOTECHNOLOGY CO., LTD.
BIOTIME MAU Rapid Quantitative Test
XIAMEN BIOTIME BIOTECHNOLOGY CO., LTD.
BIOTIME TT3 Rapid Quantitative Test
XIAMEN BIOTIME BIOTECHNOLOGY CO., LTD.
BIOTIME FIA Analyzer FLI-100
XIAMEN BIOTIME BIOTECHNOLOGY CO., LTD.
BIOTIME TSH Rapid Quantitative Test (Chemiluminescence Immunoassay)
XIAMEN BIOTIME BIOTECHNOLOGY CO., LTD.
BIOTIME Dengue IgG/IgM Rapid Test
XIAMEN BIOTIME BIOTECHNOLOGY CO., LTD.
BIOTIME Dengue NS1 Antigen Rapid Test
XIAMEN BIOTIME BIOTECHNOLOGY CO., LTD.