FOKUS hCG Pregnancy Rapid Test Dipstick - Indonesia BPOM Medical Device Registration
FOKUS hCG Pregnancy Rapid Test Dipstick is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101121377. The device is manufactured by HANGZHOU ALLTEST BIOTECH CO., LTD. from China, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. FOCUS DIAGNOSTIC INDONESIA.
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
HANGZHOU ALLTEST BIOTECH CO., LTD.Country of Origin
China
Authorized Representative
PT. FOCUS DIAGNOSTIC INDONESIAAR Address
Jl. Jatipadang Raya No.9A, RT.6/RW.4, Kelurahan Jatipadang, Kecamatan Pasar Minggu, Kota Jakarta Selatan, DKI Jakarta 12540
Registration Date
Jul 11, 2023
Expiry Date
Apr 10, 2026
Product Type
Clinical Chemistry Test System
Human chorionic gonadotropin (HCG) test system (card)
Invitro Diagnostics
UNVEIL™ 25 OH Vitamin D (25-OH VD) Test Kit (CLIA)
UNVEIL ™ Procalcitonin (PCT) Test Kit (CLIA)
ALLCALL Uric Acid Test Strip
UNVEIL™ Glycated Hemoglobin (HbA1c) Test Kit (CLIA)
UNVEIL ™ Insulin (INS) Test Kit (CLIA)
UNVEIL ™ Serum Amyloid A Protein (SAA) Test Kit (CLIA)
OPTIMUS Test Syphilis Serum One Step Diagnostic Rapid Test (Cassette)
OPTIMUS Test Tuberculosis (TB) Serum One Step Diagnostic Rapid Test (Cassette)
ALLCALL Blood Glucose/Ketone/Uric Acid/Total Cholesterol 4 in 1 Monitoring System I
AIM Rapid Test Ferritin-F
FOKUS FDI HM-3 Plus Diluent Hematology Reagent
AEHEALTH LIMITED
FlowClean Cleaning Agent
BECKMAN COULTER, INC.
FOKUS Auto 3-Diff Hematology Analyzer
AEHEALTH LIMITED
AQUIOS Cleaning Agent
BECKMAN COULTER, INC.
FOKUS FDI HM-5 Plus DIFF Lyse Hematology Reagent
AEHEALTH LIMITED
FOCUS Leptospira IgM Cassette
ZEPHYR BIOMEDICALS - A DIV. OF TULIP DIAGNOSTICS (P) LTD.
FOKUS FDI HM-5 Plus Diluent Hematology Reagent
AEHEALTH LIMITED
FOCUS Syphicheck WB device
ZEPHYR BIOMEDICALS - A DIV. OF TULIP DIAGNOSTICS (P) LTD.
FOKUS Love-Gruenwald Laminectomy Rongeur Instrument
CEATEC MEDIZINTECHNIK GMBH & CO. KG.
FOKUS Measuring Instrument Set II
CEATEC MEDIZINTECHNIK GMBH