BEUDAMED
    FDA Registration Active 🇬🇧 United Kingdom

    RENASYS Soft Port

    Reg #: 8043484 · FEI: 3002808194 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    11
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Smith & Nephew Medical Ltd
    Registration Number
    8043484
    FEI Number
    3002808194
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    101 Hessle Road
    City
    HULL East Riding of Yorkshire
    Country
    GB

    Regulatory Submissions

    510(k) Number
    K142979

    Owner / Operator

    Firm Name
    SMITH AND NEPHEW MEDICAL LTD.
    Operator Number
    9001952
    Address
    101 HESSLE RD., --
    City
    HULL
    State
    GB-NOTA
    Postal Code
    HU3 2BN
    Country
    GB
    Correspondent
    Samantha Neilson

    Products

    Device Name Product Code
    Negative Pressure Wound Therapy Powered Suction Pump OMP

    Proprietary Names

    RENASYS Soft Port RENASYS F Foam Dressing Kit with Soft Port Antimicrobial gauze roll RENASYS EZ Plus/Max 250 ml Canister RENASYS EZ MAX pump RENASYS G Sterile Gauze Dressing Kit with Soft Port RENASYS EZ Max 800ml S-Canister without solidifier RENASYS EZ Max Quick Reference Guide RENASYS EZ Plus/EZ Max 800ml S - Canister Antimicrobial gauze Foam wound dressing

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility