BEUDAMED
    FDA Registration Active 🇬🇧 United Kingdom

    Poly-Tape, Infinity Lock, AchilloCordPLUS

    Reg #: 3007663067 · FEI: 3007663067 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    Systagenix Wound Management Manufacturing Limited
    Registration Number
    3007663067
    FEI Number
    3007663067
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Airebank Mill, Gargrave
    City
    North Yorkshire
    Country
    GB

    Regulatory Submissions

    510(k) Number
    K222978

    Owner / Operator

    Firm Name
    Systagenix Wound Management Manufacturing Limited
    Operator Number
    10028771
    Address
    Airebank Mill, Gargrave
    City
    North Yorkshire
    State
    GB-NYK
    Postal Code
    BD23 3RX
    Country
    GB
    Correspondent
    Libby Morrison

    US Agent

    Business Name
    Scapa Tapes North America LLC
    Contact Name
    Randy Hall
    Address
    2565 Bertelkamp Lane
    City
    Knoxville
    State
    TN
    ZIP
    37931
    Country
    US
    Email
    [email protected]
    Phone
    865 2787235

    Products

    Device Name Product Code
    Mesh, Surgical, Non-Resorbable, Orthopedics, Reinforcement Of Ligament QUW
    Mesh, Surgical, Polymeric FTL
    Mesh, Surgical, Non-Absorbable, Orthopaedics, Reinforcement Of Tendon OWX

    Proprietary Names

    Poly-Tape, Infinity Lock, AchilloCordPLUS

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)