BEUDAMED
    FDA Registration Active 🇧🇪 Belgium

    GMED Healthcare BVBA ( a Johnson & Johnson Company)

    Reg #: 3014272734 · FEI: 3014272734 · Expires 2026
    View on FDA
    Products
    16
    Proprietary Names
    53
    Establishment Types
    1
    Classifications
    16

    Research this establishment in seconds

    The Research Assistant profiles FDA-registered establishments — listings, owners, related facilities — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Registration Details

    Registration Name
    GMED Healthcare BVBA ( a Johnson & Johnson Company)
    Registration Number
    3014272734
    FEI Number
    3014272734
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    European Distribution Centre, Rue du Luxembourg 5
    City
    Courcelles Luxembourg
    Country
    BE

    Regulatory Submissions

    510(k) Number
    K252906
    PMA Number
    P240035

    Owner / Operator

    Firm Name
    ETHICON INC.
    Operator Number
    2210968
    Address
    1000 US Highway 202 S.
    City
    Raritan
    State
    NJ
    Postal Code
    08869
    Country
    US
    Correspondent
    Reynaldo Librojo

    US Agent

    Business Name
    ETHICON Inc
    Contact Name
    Reynaldo Librojo
    Address
    1000 US Highway 202
    City
    Raritan
    State
    NJ
    ZIP
    08869
    Country
    US
    Email
    [email protected]
    Phone
    908 8086028

    Products

    Device Name Product Code
    Mesh, Surgical, Absorbable, Staple Line Reinforcement OXC
    Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence PWJ
    Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator OTN
    Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate MEH
    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented LZO
    Sterilizer, Chemical MLR
    Mesh, Surgical, Polymeric FTL
    Agent, Absorbable Hemostatic, Collagen With Polymeric Additives SGV
    Computer, Diagnostic, Programmable DQK
    Suture, Absorbable, Synthetic, Polyglycolic Acid GAM
    Suture, Surgical, Absorbable, Polydioxanone NEW
    Agent, Absorbable Hemostatic, Collagen Based LMF
    Catheter, Ultrasound, Intravascular OBJ
    Introducer, Catheter DYB
    Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed OTO
    Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented KWS

    Proprietary Names

    EES - ECHELON ENDOPATH™ Staple Line Reinforcement TVT Abdominal Guides and Couplers TVT Reusable Introducer TVT Reusable Catheter Guide BI-MENTUM PE Liner BI-MENTUM Plus Cup BI-MENTUM Revision Cup BI-MENTUM Cemented Cup BI-MENTUM PressFit Cup BI-MENTUM Screw STERRAD 100NX STERILIZER GYNECARE TVT ABBREVO and GYNECARE TVT Obturator Helical Passers and Atraumatic Winged Guide ECHELON ENDOPATH Staple Line Reinforcement GYNECARE TVT Obturator STERRAD NX STERILIZER ULTRAPRO PLUG ETHIZIA Hemostatic Patch Confidence Mapping Module GYNECARE TVT EXACT™ Continence System and Trocar GYNECARE TVT™ Introducer and Catheter Guide GYNECARE TVT™ System GYNECARE TVT ABBREVO™ Continence System and Passers and Winged Guide GYNECARE TVT™ Obturator System and Passers and Winged Guide GYNECARE TVT™ with Abdominal Guides System PDS™ II (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture PDS™ Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture VICRYL™ (Polyglactin 910) Sterile Synthetic Absorbable Surgical Suture Gynecare TVT Exact Continence System PROCEED VENTRAL PATCH SURGIFLO Hemostatic Matrix Kit SOUNDSTAR ECO SMS 8F CATHETER SOUNDSTAR ECO GE 8F CATHETER ULTRAPRO HERNIA SYSTEM SOUNDSTAR eco SMS 10F Catheter SOUNDSTAR ECO GE 10F CATHETER STERRAD 100S STERILIZER PREFACE Braided Guiding Sheath TVT Reusable Catheter Guide (instruments code 810061) TVT EXACT Trocar TVT Reusable Introducer (Instrument code 810051) Ethicon PHYSIOMESH Open Flexible Composite Mesh Artisyn Y-Shaped Mesh ACUNAV G 8F-90 CATHETER AcuNav 10F-90 Catheter ACUNAV 8F-90 ACUNAV G 10F-90 CATHETER GYNECARE TVT ABBREVO Continence System ULTRAPRO ADVANCED Mesh ULTRAPRO Mesh ULTRAPRO Comfort Plug SOUNDSTAR G 10F-90, GE GYNECARE TENSION-FREE VAGINAL TAPE SYSTEM DePuy Orthopaedics - Materialise Glenoid Positioning System

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device