BEUDAMED
    FDA Registration Active 🇭🇰 Hong Kong

    PHASE SCIENTIFIC INTERNATIONAL LIMITED

    Reg #: 3017887566 · FEI: 3017887566 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    8
    Establishment Types
    3
    Classifications
    5

    Registration Details

    Registration Name
    PHASE SCIENTIFIC INTERNATIONAL LIMITED
    Registration Number
    3017887566
    FEI Number
    3017887566
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    1/F, Building 22E Phase 3, Hong Kong Science Park
    City
    Shatin NT, HONG KONG
    Country
    HK

    Regulatory Submissions

    510(k) Number
    K150022

    Owner / Operator

    Firm Name
    Phase Scientific International Limited
    Operator Number
    10083165
    Address
    1/F. Building 22E Phase 3, Hong Kong Science Park
    City
    Shatin NT
    State
    HK-NOTA
    Postal Code
    00000
    Country
    HK
    Correspondent
    Ricky Chiu

    Products

    Device Name Product Code
    Research Use Only/Hematology Devices OTQ
    Coronavirus Antigen Detection Test System. QKP
    Visual, Pregnancy Hcg, Prescription Use JHI
    Kit, Test, Pregnancy, Hcg, Over The Counter LCX
    Research Use Only/Clinical Chemistry Devices OTV

    Proprietary Names

    PHASIFY Plasma DNA Extraction Kit-S2 Enrichment PHASIFY MAX cfDNA Extraction Kit PHASIFY ENRICH cfDNA Extraction Kit INDICAID COVID-19 Rapid Antigen Test INDICAID COVID-19 Rapid Antigen At-Home Test INDICAID™ HCG EARLY RESULT PREGNANCY TEST STRIP PHASIFY Urine DNA Extraction Kit-S2 Enrichment Phasify Total DNA Extraction Kit 2

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198 Export Device to the United States But Perform No Other Operation on Device