BEUDAMED
    EU Manufacturer 🇨🇳 China Active

    Ustar Biotechnologies (Hangzhou) Ltd.

    SRN: CN-MF-000014615 · Bldg 1, 2 & 4, 611 Dongguan Road, Binjiang District, 310053 Hangzhou, China
    View on EUDAMED
    Basic UDI-DIs
    47
    Total Devices
    48
    On Market
    48
    Off Market
    0
    Certificates
    0
    Valid
    0
    Expiring < 6mo
    0
    Countries
    2

    Basic Information

    Address
    Bldg 1, 2 & 4, 611 Dongguan Road, Binjiang District, 310053 Hangzhou, China
    Email
    [email protected]
    Phone
    86-4008707025
    Website
    http://en.bioustar.com/

    Regulatory Overview

    Regulation
    Loading...
    Eu Ivdd 25
    Eu Ivdr 22
    Classification
    Loading...
    Eu Ivd General 25
    Eu Ivd Class A 12
    Eu Ivd Class C 8
    Eu Ivd Class B 2
    Device Types
    Loading...

    Certificate Health

    No certificates registered for this manufacturer.

    Market Presence

    Devices from this manufacturer are available in 2 countries across Europe.

    🇫🇷 France 🇳🇱 Netherlands

    Device Portfolio

    Name
    BORDETELLA PERTUSSIS / PARAPERTUSSIS - NA REAGENTS
    CLINICAL CHEMISTRY REAGENTS - OTHER
    EasyNAT BP Assay
    EasyNAT CT/NG Assay
    EasyNAT GBS Assay
    EasyNAT MG Assay
    EasyNAT MP Assay
    EasyNAT MTC Assay
    EasyNAT Rapid Flu Assay
    EasyNAT Rapid RSV Assay
    EasyNAT UU Assay
    EasyNAT HSV 1&2 Assay
    H. PYLORI DETECTION BY NA REAGENTS
    HSV - NA REAGENTS
    INFLUENZA & PARA INFLUENZA - NA REAGENTS
    LEGIONELLA DETECTION BY NA REAGENTS
    MYCOBACTERIAL DETECTION BY NA REAGENTS
    MYCOPLASMA DETECTION BY NA REAGENTS
    MYCOPLASMA DETECTION BY NA REAGENTS
    MYCOPLASMA DETECTION BY NA REAGENTS
    MuItNAT SARS-CoV-2/Flu and RSV PCR Assay
    MultNAT Molecular Diagnostic Testing System
    MultNAT Molecular Diagnostic Testing System
    NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS
    NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS
    NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS
    NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS
    NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS
    NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS
    NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS
    OTHER HPV - NA REAGENTS
    OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS
    PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS
    PLASMODIUM (MALARIA)
    REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS
    REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS
    REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS
    REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS
    REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS
    REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS
    RESPIRATORY SYNCYTIAL VIRUS (RSV) - NA REAGENTS
    SAMPLES COLLECTION DEVICES - OTHER
    SAMPLES COLLECTION DEVICES - OTHER
    SAMPLES COLLECTION DEVICES - OTHER
    SAMPLES COLLECTION DEVICES - OTHER
    STREP. PNEUMONIAE DETECTION BY NA REAGENTS
    STREPTOCOCCAL DETECTION BY NA REAGENTS
    VIROLOGY - NA REAGENTS - OTHER