FOKUS HS-CRP/CRP (High Sensitivity C-reactive Protein/ C-reactive Protein) Rapid Quantitative Test (Immunofluorescence Assay) - Indonesia BPOM Medical Device Registration
FOKUS HS-CRP/CRP (High Sensitivity C-reactive Protein/ C-reactive Protein) Rapid Quantitative Test (Immunofluorescence Assay) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20305126684. The device is manufactured by SHENZHEN AEHEALTH TECHNOLOGY 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
SHENZHEN AEHEALTH TECHNOLOGY CO., LTDCountry 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 04, 2024
Expiry Date
Jul 03, 2027
Product Type
Immunological Test System
C-reactive protein immunological test system.
Invitro Diagnostics
FOKUS IL-6 (Interleukin- 6) Rapid Quantitative Test (Immunofluorescence Assay)
FOKUS T4 (Total Thyroxine) Rapid Quantitative Test (Immunofluorescence Assay)
FOKUS T3 (Total Triiodothyronine) Rapid Quantitative Test (Immunofluorescence Assay)
FOKUS MAU (Microalbumin) Rapid Quantitative Test (Immunofluorescence Assay)
FOKUS 25-(OH)-VD (25-OH Vitamin D) Rapid Quantitative Test (Immunofluorescence Assay)
FOKUS PSA (Prostate Specific Antigen) Rapid Quantitative Test (Immunofluorescence Assay)
FOKUS FT4 (Free Thyroxine) Rapid Quantitative Test (Immunofluorescence Assay)
FOKUS FT3 (Free Triiodothyronine) Rapid Quantitative Test (Immunofluorescence Assay)
FOKUS PCT (Procalcitonin) Rapid Quantitative Test (Immunofluorescence Assay)
FOKUS cTnT (Cardiac troponin T) Rapid Quantitative Test (Immunofluorescence Assay)
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