BEUDAMED
    FDA Registration Active 🇨🇭 Switzerland

    PENTAPHARM AG

    Reg #: 1000340866 · FEI: 1000340866 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    5

    Registration Details

    Registration Name
    PENTAPHARM AG
    Registration Number
    1000340866
    FEI Number
    1000340866
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Dornacherstr. 112
    City
    Aesch Basel-Landschaft
    Country
    CH

    Regulatory Submissions

    510(k) Number
    K042762

    Owner / Operator

    Firm Name
    Pentapharm AG
    Operator Number
    9083272
    Address
    Dornacherstrasse 112, --
    City
    Aesch
    State
    Basel-Landschaft
    Postal Code
    4147
    Country
    CH
    Correspondent
    Vincent Muller

    US Agent

    Business Name
    Pentapharm LLC
    Contact Name
    Michael McGuire
    Address
    270 Greenwich Ave Ste 9
    City
    Greenwich
    State
    CT
    ZIP
    06830
    Country
    US
    Email
    [email protected]
    Phone
    800 7973850

    Products

    Device Name Product Code
    Test, Time, Partial Thromboplastin GGW
    Plasma, Control, Normal GIZ
    System, Multipurpose For In Vitro Coagulation Studies JPA
    Control, Plasma, Abnormal GGC
    Plasma, Coagulation Control GGN

    Proprietary Names

    PEFAKIT APC-R Factor V Leiden PEFAKIT APC-R Factor V Leiden Controls

    Establishment Types

    Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)