BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SPY Laparoscope, Autoclavable, 5.4 mm x 0, 30cm

    Reg #: 3020142503 · FEI: 3020142503 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    12
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    OMEC MEDICAL NV INC
    Registration Number
    3020142503
    FEI Number
    3020142503
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    5690 Riggins CT
    City
    Reno
    State
    NV
    ZIP
    89502
    Country
    US

    Regulatory Submissions

    510(k) Number
    K221217

    Owner / Operator

    Firm Name
    OMEC Medical NV Inc.
    Operator Number
    10082628
    Address
    5690 Riggins CT, Suite B
    City
    Reno
    State
    NV
    Postal Code
    89502
    Country
    US
    Correspondent
    Anmin Zheng

    Products

    Device Name Product Code
    Laparoscope, General & Plastic Surgery GCJ

    Proprietary Names

    SPY Laparoscope, Autoclavable, 5.4 mm x 0, 30cm SPY Bariatric Laparoscope, Autoclavable, 10mm x 45, 45cm SPY Bariatric Laparoscope, Autoclavable, 10mm x 0, 45cm SPY Laparoscope, Autoclavable, 5.4 mm x 30, 30cm SPY Laparoscope, Autoclavable, 10mm x 0, 33cm SPY Bariatric Laparoscope, Autoclavable, 5.4 mm x 45, 45cm SPY Laparoscope, Autoclavable, 10mm x 45, 33cm SPY Bariatric Laparoscope, Autoclavable, 5.4 mm x 0, 45cm SPY Laparoscope, Autoclavable, 10mm x 30, 33cm SPY Bariatric Laparoscope, Autoclavable, 10mm x 30, 45cm SPY Bariatric Laparoscope, Autoclavable, 5.4 mm x 30, 45cm SPY Laparoscope, Autoclavable, 5.4 mm x 45, 30cm

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)