BEUDAMED
    FDA Registration Active 🇳🇱 Netherlands

    PNEUMO SURE XL HIGH FLOW INSUFFLATOR

    Reg #: 3008837339 · FEI: 3008837339 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    STRYKER EMEA Supply Chain Services
    Registration Number
    3008837339
    FEI Number
    3008837339
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Frans Maasweg 2
    City
    Venlo Limburg
    Country
    NL

    Regulatory Submissions

    510(k) Number
    K063367

    Owner / Operator

    Firm Name
    STRYKER CORP.
    Operator Number
    1811755
    Address
    4100 East Milham Ave.
    City
    Kalamazoo
    State
    MI
    Postal Code
    49001
    Country
    US

    Products

    Device Name Product Code
    Insufflator, Laparoscopic HIF

    Proprietary Names

    PNEUMO SURE XL HIGH FLOW INSUFFLATOR PNEUMO SURE XL HIGH FLOW INSUFFLATOR W/O SIDNE (EU1) PNEUMO SURE HIGH FLOW INSUFFLATOR WITH SIDNE PNEUMO SURE XL HIGH FLOW INSUFFLATOR WITH SIDNE PNEUMO SURE HIGH FLOW INSUFFLATOR WITHOUT SIDNE PNEUMO SURE HIGH FLOW INSUFFLATOR

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device