BEUDAMED
    FDA Registration Active 🇮🇱 Israel

    DEGANIA SILICONE, LTD.

    Reg #: 8030107 · FEI: 7682 · Expires 2026
    View on FDA
    Products
    22
    Proprietary Names
    20
    Establishment Types
    3
    Classifications
    22

    Registration Details

    Registration Name
    DEGANIA SILICONE, LTD.
    Registration Number
    8030107
    FEI Number
    7682
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    KIBBUTZ
    City
    DEGANIA BET Northern
    Country
    IL

    Regulatory Submissions

    510(k) Number
    K143378

    Owner / Operator

    Firm Name
    QMD
    Operator Number
    8030107
    Address
    DEGANIA BET
    City
    Degania Bet
    State
    Northern
    Postal Code
    1513000
    Country
    IL
    Correspondent
    Tal - Gafni

    Products

    Device Name Product Code
    Gastrointestinal Tubes With Enteral Specific Connectors PIF
    Tubes, Gastrointestinal (And Accessories) KNT
    Tubing, Fluid Delivery FPK
    Catheter, Retention Type, Balloon EZL
    Cystoscope And Accessories, Flexible/Rigid FAJ
    Apparatus, Suction, Single Patient Use, Portable, Nonpowered GCY
    Catheter, Upper Urinary Tract EYC
    Elastomer, Silicone, For Scar Management MDA
    Shield, Nipple HFS
    Tube, Feeding FPD
    Scissors, General, Surgical LRW
    Dilator, Cervical, Hygroscopic-Laminaria HDY
    Clamp, Vascular DXC
    Drape, Surgical, Exempt PUI
    Balloon Gastrostomy Tube Kit PRP
    Catheter, Ventricular, General & Plastic Surgery GBS
    Endoscopic Guidewire, Gastroenterology-Urology OCY
    Catheter, Irrigation GBX
    Tourniquet, Nonpneumatic GAX
    Catheter, Urological KOD
    Percutaneous Replacement Gastrostomy Tube Kit PSH
    Device, Irrigation, Ocular Surgery KYG

    Proprietary Names

    Tubing Realize Gastric calibration Tube Silicone Bulb Reservoirs SIL-K IDENTI-LOOPS SILICLAMPS Gentle feed nipple shields GENTLE FEED NIPPLE SHIELDS Straight Scissors for PEG kit Cervical Ripening Balloon Catheter Drape for PEG kit Gastrostomy Replacement Tube with Lubricant Jelly Silicone thoracic catheter Peg Kit Looped Placement Wire for PEG kit Cardivascular clamps DEGANIA SILICONE TOURNIQUET Low Profile Gastrostomy Feeding Tube Kit Low-profile Gastrostomy Feeding Tube Kit with Stylus Stylus ophthalmic bottle

    Establishment Types

    Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer) Develop Specifications But Do Not Manufacture At This Facility