BEUDAMED
    Authorized Representative 🇩🇪 Germany Active

    IMMUCOR Medizinische Diagnostik GmbH

    SRN: DE-AR-000007083 · Robert-Bosch-Straße 32, 63303 Dreieich, Germany
    View on EUDAMED
    Manufacturers
    4
    Devices
    36
    Certificates
    2
    PRRCs
    3

    Basic Information

    Address
    Robert-Bosch-Straße 32, 63303 Dreieich, Germany
    Email
    [email protected]
    Phone
    +49 6103 8056 0
    Website
    www.immucor.com
    VAT Number
    DE113560056
    EORI
    DE2509059

    Non-EU Manufacturers

    Name
    Immucor GTI Diagnostics, Inc
    Dominion Biologicals Limited
    BioArray Solutions Ltd
    Immucor, Inc.

    Manufacturers

    Immucor GTI Diagnostics, Inc

    Manufacturer
    🇺🇸 United States·8 Basic UDI-DIs·8 Devices·TÜV Rheinland LGA Products GmbH

    BioArray Solutions Ltd

    Manufacturer
    🇺🇸 United States·1 Basic UDI-DI·1 Device

    Dominion Biologicals Limited

    Manufacturer
    🇨🇦 Canada·TÜV Rheinland LGA Products GmbH

    Immucor, Inc.

    Manufacturer
    🇺🇸 United States·27 Basic UDI-DIs·27 Devices

    Certificates

    Type Number
    IVDR QMS HX 1804149-1
    IVDR QMS HX 1804155-1

    Devices

    Nuclease-Free Water

    Device
    EU IVDR · Eu Ivd Class A ·Immucor GTI Diagnostics, Inc·On the market·32 countries

    Streptavidin-PE

    Device
    EU IVDR · Eu Ivd Class A ·Immucor GTI Diagnostics, Inc·On the market·32 countries

    LIFECODES Taq Polymerase

    Device
    EU IVDR · Eu Ivd Class A ·Immucor GTI Diagnostics, Inc·On the market·32 countries

    Concentrated Wash

    Device
    EU IVDR · Eu Ivd Class A ·Immucor GTI Diagnostics, Inc·On the market·32 countries

    PF4 Concentrated Wash

    Device
    EU IVDR · Eu Ivd Class A ·Immucor GTI Diagnostics, Inc·On the market·32 countries

    Specimen Diluent

    Device
    EU IVDR · Eu Ivd Class A ·Immucor GTI Diagnostics, Inc·On the market·32 countries

    Dilution Solution

    Device
    EU IVDR · Eu Ivd Class A ·Immucor GTI Diagnostics, Inc·On the market·32 countries

    LIFECODES Wash Buffer

    Device
    EU IVDR · Eu Ivd Class A ·Immucor GTI Diagnostics, Inc·On the market·32 countries

    BioArray Array Imaging System TM (AIS) 400D

    Device
    EU IVDR · Eu Ivd Class A ·BioArray Solutions Ltd·On the market·5 countries

    ImmuLINK®

    Device
    EU IVDR · Eu Ivd Class A ·Immucor, Inc.·On the market·32 countries

    Gamma-clone Anti-Cw (Monoclonal) Blood Grouping Reagent

    Device
    EU IVDR · Eu Ivd Class C ·Immucor, Inc.·On the market·32 countries

    Anti-IgG,-C3d (Murine Monoclonal); Polyspecific, Gamma-clone

    Device
    EU IVDR · Eu Ivd Class C ·Immucor, Inc.·On the market·32 countries

    ENZYMES (E.G. BROMELIN / PAPAIN, ETC.)

    Device
    EU IVDR · Eu Ivd Class C ·Immucor, Inc.·On the market·32 countries

    Freeze-Dried Papain

    Device
    EU IVDR · Eu Ivd Class C ·Immucor, Inc.·On the market·32 countries

    GammaZyme-F

    Device
    EU IVDR · Eu Ivd Class C ·Immucor, Inc.·On the market·32 countries

    GammaZyme-B

    Device
    EU IVDR · Eu Ivd Class C ·Immucor, Inc.·On the market·32 countries

    Complement Control Cells

    Device
    EU IVDR · Eu Ivd Class C ·Immucor, Inc.·On the market·32 countries

    DAT Positive Control Cell (1 x 10 mL)

    Device
    EU IVDR · Eu Ivd Class C ·Immucor, Inc.·On the market·32 countries

    Gamma Lewis Blood Group Substance

    Device
    EU IVDR · Eu Ivd Class C ·Immucor, Inc.·On the market·32 countries

    RESt (Rabbit Erythrocyte Stroma)

    Device
    EU IVDR · Eu Ivd Class C ·Immucor, Inc.·On the market·32 countries

    Gamma EGA Kit

    Device
    EU IVDR · Eu Ivd Class C ·Immucor, Inc.·On the market·32 countries

    H.P.C. (Human Platelet Concentrate)

    Device
    EU IVDR · Eu Ivd Class C ·Immucor, Inc.·On the market·32 countries

    Gamma ELU-KIT II

    Device
    EU IVDR · Eu Ivd Class C ·Immucor, Inc.·On the market·32 countries

    Anti-k (Monoclonal) (IgG) Gamma-clone Blood Grouping Reagent

    Device
    EU IVDR · Eu Ivd Class C ·Immucor, Inc.·On the market·32 countries

    Anti-Kpb - Blood Grouping Reagent

    Device
    EU IVDR · Eu Ivd Class C ·Immucor, Inc.·On the market·32 countries

    Anti-Leb (Murine Monoclonal) Gamma-clone Blood Grouping Reagent

    Device
    EU IVDR · Eu Ivd Class C ·Immucor, Inc.·On the market·32 countries

    Anti-Kpa Blood Grouping Reagent

    Device
    EU IVDR · Eu Ivd Class C ·Immucor, Inc.·On the market·32 countries

    Gamma P1 Blood Group Substance

    Device
    EU IVDR · Eu Ivd Class C ·Immucor, Inc.·On the market·32 countries

    Automated C3d plate

    Device
    EU IVDR · Eu Ivd Class C ·Immucor, Inc.·On the market·32 countries

    Anti-Lea (Murine Monoclonal) Gamma-clone Blood Grouping Reagent

    Device
    EU IVDR · Eu Ivd Class C ·Immucor, Inc.·On the market·32 countries

    Platelet Wash and Storage Solution

    Device
    EU IVDR · Eu Ivd Class A ·Immucor, Inc.·On the market·32 countries

    Galileo Echo

    Device
    EU IVDR · Eu Ivd Class A ·Immucor, Inc.·On the market·32 countries

    ECHO Lumena

    Device
    EU IVDR · Eu Ivd Class A ·Immucor, Inc.·On the market·32 countries

    Specimen Diluent

    Device
    EU IVDR · Eu Ivd Class A ·Immucor, Inc.·On the market·32 countries

    Red Blood Cell (RBC) Storage Solution

    Device
    EU IVDR · Eu Ivd Class A ·Immucor, Inc.·On the market·32 countries

    CMT Plates

    Device
    EU IVDR · Eu Ivd Class A ·Immucor, Inc.·On the market·32 countries