BEUDAMED
    FDA Registration Active 🇬🇧 United Kingdom

    GYRUS MEDICAL LTD.

    Reg #: 9617070 · FEI: 3002807134 · Expires 2026
    View on FDA
    Products
    12
    Proprietary Names
    85
    Establishment Types
    1
    Classifications
    12

    Registration Details

    Registration Name
    GYRUS MEDICAL LTD.
    Registration Number
    9617070
    FEI Number
    3002807134
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    FORTRAN RD., ST. MELLONS
    City
    CARDIFF Wales
    Country
    GB

    Owner / Operator

    Firm Name
    ATL Technology LLC
    Operator Number
    10045899
    Address
    1335 West 1650 North
    City
    Springville
    State
    UT
    Postal Code
    84663
    Country
    US

    US Agent

    Business Name
    ATL Technology
    Contact Name
    Lauren Cordova
    Address
    1335 W 1650 N
    City
    Springville
    State
    UT
    ZIP
    84663
    Country
    US
    Email
    [email protected]
    Phone
    801 8534035 ext. 235

    Products

    Device Name Product Code
    Hysteroscope (And Accessories) HIH
    Coagulator-Cutter, Endoscopic, Unipolar (And Accessories) KNF
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Unit, Electrosurgical, Endoscopic (With Or Without Accessories) KNS
    Arthroscope HRX
    Resectoscope, Working Element FDC
    Coagulator-Cutter, Endoscopic, Bipolar (And Accessories) HIN
    Electrode, Electrosurgical, Active, Urological FAS
    Resectoscope FJL
    Coagulator, Laparoscopic, Unipolar (And Accessories) HFG
    Gastroscope And Accessories, Flexible/Rigid FDS
    Coagulator, Culdoscopic (And Accessories) HFI

    Proprietary Names

    Versapoint Bipolar Electrode Resectoscopic Vaporizing Tip (0°) PLASMAKINETIC SUPERPULSE SYSTEM PK SuperLoop Instrument PLASMAKINETIC SUPERPULSE SYSTEM PK SuperSect Instrument PLASMAKINETIC SUPERPULSE SYSTEM Footswitch PLASMAKINETIC SUPERPULSE SYSTEM SuperLoop PK Front Loading Electrode PLASMAKINETIC SUPERPULSE SYSTEM SuperSect PK Front Loading Electrode VAPR CoolPulse 90 Electrode with Hand Controls VAPR Premiere90 with Integrated Handpiece VAPR S50 Electrode with Integrated Handpiece VAPR CoolPulse 90 Electrode without Hand Controls VAPR Premiere50 Electrode with Integrated Handpiece Single Use Plasma Coagulation Probe Axial Argon PA-211U, 2.3 x 2200 mm Single Use Plasma Coagulation Probe Lateral Argon PA-221U, 2.3 x 2200 mm Pressure reducer, with connector acc. to CGA No. 580, for Argon Plasma Coagulation Single Use Plasma Coagulation Probe Axial Argon PA-211Z, 2.3 x 3000 mm Single Use Plasma Coagulation Probe Axial Argon PA-212U, 3.2 x 2200 mm Single Use Plasma Coagulation Probe Axial Argon PA-210K, 1.5 x 1500 mm Single Use Plasma Coagulation Probe Radial Argon PA-231U, 2.3 x 2200 mm Single Use Plasma Coagulation Probe Axial Argon PA-210Z, 1.5 x 3000 mm VAPR 2.3 Wedge Electrode VAPR® 2.3 Wedge Electrode (Short) PK Plasma-V Instrument Versapoint II Connector Cable Versapoint II Bipolar Electrode Resectoscopic 4 mm Angled Loop, Resecting Versapoint II Electrosurgical Generator Versapoint II Footswitch VAPR Flexible Side Effect Electrode VAPR End Effect Electrode VAPR Side Effect Electrode VAPR 90 Degree Hook Electrode VAPR Flexible End Effect Electrode VAPR Angled Side Effect Electrode VAPR Angled End Effect Electrode VAPR Handpiece VAPR S90 Electrode VAPR 3 Footswitch Monopolar Single-Use HF Cable PK Lap Loop VAPR 2.3 Side Effect Electrode VAPR 2.3 Side Effect Electrode (Short) VAPR Premiere50 VAPR S50 Electrode VAPR® Premiere90 VAPR P50 Hand Switching VAPR Hook Hand Switching VAPR 2.3 Wedge Hand Switching VAPR Side Effect Hand Switching VAPR VUE Wireless Footswitch VAPR VUE Generator VAPR S90 Hand Switching PLASMAKINETIC SYSTEM PK Plasma-Sect Instrument - Angled Loop Resecting PLASMAKINETIC SYSTEM PK Plasma-Sect Instrument - Angled Loop Resecting 4mm VAPR Hook Electrode with Integrated Handpiece VAPR Premiere50 Electrode Integrated Handpiece VAPR S90 Electrode with Integrated Handpiece VAPR Side Effect Electrode with Integrated Handpiece VAPR 2.3 Wedge Electrode with Integrated Handpiece VAPR® 2.3 End Effect Electrode Versapoint Bipolar Electrode Resectoscopic 2.5 mm Angled Loop, Resecting PK Button VAPR Tripolar 90 Suction Electrode VAPR CoolPulse Curve Suction Electrode XL VAPR CoolPulse Curve Suction Electrode VAPR Hook Electrode VAPR Premiere50 Electrode PLASMAKINETIC SYSTEM PK Plasma-V Instrument VAPR ARCTIC Suction Electrode Chisel Tip VAPR ARCTIC Suction Electrode Dome Tip VAPR Temperature Control End Effect Electrode Versapoint Bipolar Electrode - Twizzle Tip (5 Pack) Versapoint Bipolar Electrode - Spring Tip (5Pack) Versapoint Connector Cable VAPR Flexible Side Effect Electrode with Integrated Handpiece VAPR Side Effect Electrode with Hand Controls 3.5mm Side Effect with Integrated Handpiece VAPR S50 Electrode 50° Suction with Integrated Handpiece VAPR 2.3 Wedge Electrode with Hand Controls 2.3mm, with Integrated Handpiece VAPR Angled Side Effect Electrode with Integrated Handpiece VAPR 2.3 Side Effect Electrode (Short) with Integrated Handpiece VAPR Premiere50 Electrode with Hand Controls 3mm, 50° Suction with Integrated Handpiece VAPR S90 Electrode with Hand Controls 4mm, 90° Suction with Integrated Handpiece VAPR Temperature Control End Effect Electrode with Integrated Handpiece VAPR 2.3 Wedge Electrode (Short) with Integrated Handpiece VAPR Hook Electrode with Hand Controls 3.5mm Hook Electrode with Integrated Handpiece VAPR Premiere50 Electrode 50° Suction with Integrated Handpiece VAPR 2.3 End Effect Electrode with Integrated Handpiece

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)