BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    ANDREAS HETTICH GMBH

    Reg #: 3005990076 · FEI: 3005990076 · Expires 2026
    View on FDA
    Products
    10
    Proprietary Names
    28
    Establishment Types
    4
    Classifications
    10

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    Registration Details

    Registration Name
    ANDREAS HETTICH GMBH
    Registration Number
    3005990076
    FEI Number
    3005990076
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    FOEHRENSTRASSE 12
    City
    TUTTLINGEN Baden-Wurttemberg
    Country
    DE

    Owner / Operator

    Firm Name
    Andreas Hettich GmbH
    Operator Number
    9020624
    Address
    Foehrenstrasse 12
    City
    Tuttlingen
    State
    Baden-Wurttemberg
    Postal Code
    78532
    Country
    DE
    Correspondent
    Darrall - Pride

    US Agent

    Business Name
    HETTICH INSTRUMENTS LP
    Contact Name
    Darrall Pride
    Address
    100 CUMMINGS CENTER, Ste 136L
    City
    BEVERLY
    State
    MA
    ZIP
    01915
    Country
    US
    Email
    [email protected]
    Phone
    978 5663325

    Products

    Device Name Product Code
    Centrifuge, Blood-Bank For In Vitro Diagnostic Use KSO
    Centrifuge For Preparation Of Cell Concentrate And/Or Plasma Concentrate QBV
    Accessories, Implant, Dental, Endosseous NDP
    Bath, Incubators/Water, All JTQ
    Hematocrit, Tube, Rack, Sealer, Holder GHY
    Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use JQC
    Device, Hematocrit Measuring JPI
    Cytocentrifuge IFB
    Centrifuge, Hematocrit GKG
    Platelet And Plasma Separator For Bone Graft Handling ORG

    Proprietary Names

    Rotina 380 robotic EBA 200 EBA200S EBA 280S EBA 270 EBA 280 Mikro 185 Blood Bank Centrifuge Rotanta 460 robotic Rotina 380R robotic Rotanta 46 RSC ROTO SILENTA 630RS ROTIXA 500RS Rotofix 32A (MD) Intra-Spin System HettCube Hematocrit Capillaries 2074, Standard, Heparinized Sealing Putty 2077 EBA 200S Hematocrit Rotor 1650 for UNIVERSAL 320 and UNIVERSAL 320 R Hematocrit Rotor 1023 for MIKRO 220 and MIKRO 220 R Hematocrit Rotor 2076 for HAEMATOKRIT 200 Cyto Centrifuge HAEMATOKRIT 200 UNIVERSAL 320 UNIVERSAL 320R MIKRO 220R MIKRO 220

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device for Another Party (Contract Manufacturer) Repack or Relabel Medical Device