BEUDAMED
    FDA Registration Active 🇬🇧 United Kingdom

    Smith & Nephew Medical Ltd

    Reg #: 8043484 · FEI: 3002808194 · Expires 2026
    View on FDA
    Products
    22
    Proprietary Names
    154
    Establishment Types
    3
    Classifications
    22

    Registration Details

    Registration Name
    Smith & Nephew Medical Ltd
    Registration Number
    8043484
    FEI Number
    3002808194
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    101 Hessle Road
    City
    HULL East Riding of Yorkshire
    Country
    GB

    Regulatory Submissions

    510(k) Number
    K050030

    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
    Dressing, Wound, Hydrogel Without Drug And/Or Biologic NAE
    Dressing, Wound, Drug FRO
    Negative Pressure Wound Therapy Powered Suction Pump OMP
    Wound Dressing With Animal-Derived Material(S) KGN
    Dressing, Wound, Occlusive NAD
    Mesh, Surgical, Polymeric FTL
    Solvent, Adhesive Tape KOX
    Bandage, Liquid KMF
    Lavage, Jet FQH
    Topical Approximation System MZR
    Bandage, Liquid, Skin Protectant NEC
    Gauze / Sponge,Nonresorbable For External Use NAB
    Drape, Surgical, Exempt PUI
    Negative Pressure Wound Therapy Device For Reduction Of Wound Complications QFC
    Elastomer, Silicone, For Scar Management MDA
    Bag, Drainage, With Adhesive, Ostomy FON
    Monitor, Bed Patient KMI
    Protector, Skin Pressure FMP
    Beads, Hydrophilic, For Wound Exudate Absorption KOZ
    Dressing, Wound, Hydrophilic NAC
    Bandage, Elastic FQM
    Tape And Bandage, Adhesive KGX

    Proprietary Names

    INTRASITE Conformable INTRASITE Gel SOLOSITE Gel SOLOSITE Conformable ACTICOAT EXFIX ACTICOAT Site ACTICOAT Moisture Control ACTICOAT Post Op RENASYS Wound+ Dressing Kit with AIRLOCK Technology BIOBRANE Glove BIOBRANE Dressing ALLEVYN Ag+ ACTICOAT FLEX 7 ACTICOAT FLEX 3 ACTICOAT FLEX PROGUIDE Wound Contact Layer ALLEVYN Thin CUTINOVA Hydro ALLEVYN Gentle ALLEVYN Gentle Border ALLEVYN Tracheostomy ALLEVYN Adhesive ALLEVYN Non Adhesive ALLEVYN LIFE Non-Bordered RENASYS Adhesive Gel Patch REPLICARE REPLICARE Thin REPLICARE Ultra ALLEVYN Gentle Border Lite ALLEVYN Gentle Border Sacrum ALLEVYN Gentle Border Multisite ALLEVYN Gentle Border Heel ALLEVYN Life ALLEVYN Complete Care RENASYS AB Abdominal dressing kit with soft port device Unisolve Adhesive Remover Remove Adhesive Remover RENASYS-WF White foam NPWT Dressing IODOFLEX pads CUTICERIN VERSAJET II Hydrosurgery System console VERSAJET II Footswitch VERSAJET II Exact handpiece 45 deg / 8 mm VERSAJET II Plus handpiece 45 deg / 14 mm VERSAJET II Exact handpiece 45 deg / 14 mm VERSAJET II Plus handpiece 45 deg / 8 mm VERSAJET II Exact handpiece 15 deg / 14 mm VERSAJET II Plus handpiece 15 deg / 14 mm ALLEVYN Ag Adhesive ALLEVYN Ag Non Adhesive ALLEVYN Ag Gentle Border ALLEVYN Ag Dressing LEUKOSTRIP S LEUKOSTRIP COVERSTRIP IODOSORB Gel RENASYS F Foam Dressing Kit with Soft Port Foam wound dressing RENASYS G Sterile Gauze Dressing Kit with Soft Port Antimicrobial gauze RENASYS Soft Port RENASYS EZ Max 800ml S-Canister without solidifier RENASYS EZ Plus/EZ Max 800ml S - Canister RENASYS EZ MAX pump RENASYS EZ Max Quick Reference Guide Antimicrobial gauze roll RENASYS EZ Plus/Max 250 ml Canister SKIN-PREP NO-STING SKIN-PREP NOVIX Primer+Cleanser RENASYS G Gauze Dressing Kits with Soft Port TRICOTEX PROFORE WOUND CONTACT LAYER OPSITE ACTICOAT Surgical Renasys-F XL Foam Dressing Kit With Soft Port Renasys XL Transparent Film Dressing RENASYS TOUCH PICO 14 Single Use Negative Pressure Wound Therapy System PICO 7Y Single Use Negative Pressure Wound Therapy System PICO 7 Single Use Negative Pressure Wound Therapy System CICA CARE IODOFLEX Paste TINCTURE OF BENZOIN BANISH II LIQUID DEODORANT URI-KLEEN DETERGENT LEAF Patient Monitoring System LEAF Patient Monitoring System Next Generation RENASYS GO Canister 300ml RENASYS GO Power supply RENASYS GO Pump RENASYS GO Canister 750ml RENASYS GO Odor filter RENASYS GO clinician manual RENASYS GO Carry Strap RENASYS GO Home healthcare user manual RENASYS GO Rubber Feet RENASYS GO Carry Case RENASYS GO 'O' ring RENASYS GO Quick reference guide ALLEVYN LIFE ACTICOAT ACTICOAT 7 VERSAJET III Hydrosurgery System EXU-DRY Burn Dressing CONFORMANT 2 DURAFIBER Melolite ALGISITE M Melolin PROFORE PROGUIDE PROFORE LITE RENASYS EDGE 300ml Canister with Solidifier RENASYS EDGE 800ml Canister with Solidifier RENASYS EDGE 800ml Canister RENASYS EDGE Carry Bag RENASYS EDGE Power Supply RENASYS EDGE Carry Strap RENASYS EDGE RENASYS EDGE 300ml Canister DURAFIBER Ag OPSITE Flexifix Gentle OPSITE Flexifix IV3000 1-Hand IV3000 1-Hand Ported IV3000 PRIMAPORE OPSITE Post Op OPSITE Post Op Visible IV 3000 Frame Delivery COVRSITE IV3000 Standard IV3000 Ported COVRSITE Plus OPSITE Flexigrid Infustion Set IV3000 Primafix RENASYS Y-Connector (66020971) PICO Single Use Negative Pressure Wound Therapy System RENASYS Touch O-Ring RENASYS Touch 300ml canister with solidifier RENASYS Touch Carry Bag RENASYS Touch Clinician User Manual RENASYS Touch Odor Filter RENASYS Touch Power supply RENASYS Touch RENASYS Touch Power cord RENASYS Touch Carry Strap RENASYS Touch 800ml canister with solidifier RENASYS Touch Negative Pressure Wound Therapy RENASYS Y-Connector RENASYS Touch IV Pole/Bed clamp RENASYS Touch 300ml canister without solidifier

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198