BEUDAMED
    FDA Registration Active 🇺🇸 United States

    EAGLE-FL Single Lumen Ovum Pickup Needles with Flushing Line

    Reg #: 3005987240 · FEI: 3005987240 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    11
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ALLWIN MEDICAL DEVICES, INC.
    Registration Number
    3005987240
    FEI Number
    3005987240
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    3305 E. MIRALOMA AVENUE, SUITE 176
    City
    ANAHEIM
    State
    CA
    ZIP
    92806
    Country
    US

    Regulatory Submissions

    510(k) Number
    K190590

    Owner / Operator

    Firm Name
    ALLWIN MEDICAL DEVICES, INC.
    Operator Number
    9094082
    Address
    3305 E. Miraloma Ave, SUITE 176
    City
    Anaheim
    State
    CA
    Postal Code
    92806
    Country
    US
    Correspondent
    Digish D Mehta

    Products

    Device Name Product Code
    Needle, Assisted Reproduction MQE

    Proprietary Names

    EAGLE-FL Single Lumen Ovum Pickup Needles with Flushing Line ACE-FL Single Lumen Ovum Pickup Needle with Flushing Line 16G, 17G, 18G ACE-M Manual Single Lumen Ovum Pickup Needle 16G, 17G, 18G OVUMPICK Double Lumen Ovum Pickup Needle 16G, 17G ACE Single Lumen Ovum Pickup Needle 16G, 17G, 18G Eagle Single Lumen Ovum Pickup Needle 17G DUALFLOW Double Lumen Ovum Pickup Needle 17G OPICK Double Lumen Ovum Pickup Needle FALCON Single Lumen Ovum Pickup Needle 17G EAGLE-M Manual Single Lumen Ovum Pickup Needle ASPI Aspiration Needle 18G, 22G

    Establishment Types

    Manufacture Medical Device