BEUDAMED
    FDA Registration Active 🇮🇹 Italy

    TECRES SPA

    Reg #: 9614841 · FEI: 3002808402 · Expires 2026
    View on FDA
    Products
    23
    Proprietary Names
    88
    Establishment Types
    3
    Classifications
    23

    Registration Details

    Registration Name
    TECRES SPA
    Registration Number
    9614841
    FEI Number
    3002808402
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    VIA ANDREA DORIA 6, SOMMACAMPAGNA
    City
    VERONA Veneto
    Country
    IT

    Regulatory Submissions

    510(k) Number
    K143100

    Owner / Operator

    Firm Name
    TECRES SPA
    Operator Number
    9033624
    Address
    VIA ANDREA DORIA 6, --
    City
    SOMMACAMPAGNA VERONA
    State
    IT-NOTA
    Postal Code
    37066
    Country
    IT
    Correspondent
    MICHELE - PERRINO

    Products

    Device Name Product Code
    Bone Cement, Antibiotic MBB
    Bone Cement LOD
    Arthroscope HRX
    Tamp HXG
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer JWH
    Prosthesis, Hip, Hemi-, Femoral, Metal KWL
    Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented KWY
    Mixer, Cement, For Clinical Use JDZ
    Spinal Channeling Instrument, Vertebroplasty OCJ
    Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented HSD
    Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented KWS
    Cement, Bone, Vertebroplasty NDN
    Injector, Vertebroplasty (Does Not Contain Cement) OAR
    Holder, Needle; Orthopedic HXK
    Dispenser, Cement KIH
    Prosthesis, Elbow, Constrained, Cemented JDC
    Orthopedic Manual Surgical Instrument LXH
    Kit, Surgical Instrument, Disposable KDD
    Template HWT
    Orthosis, Spinal Pedicle Fixation MNI
    Bone Cement, Posterior Screw Augmentation PML
    Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer KWZ
    Prosthesis, Hip, Cement Restrictor JDK

    Proprietary Names

    Rally HV AB Bone Cement 40 Grams Rally MV AB Bone Cement 40 Grams Rally HV AB All In One System 70 Grams Rally MV AB All In One System 70 Grams Mendec Kypho Set Monolateral Kyphoplasty Balloon Catheter Mendec Kypho Set Bilateral Bowl and Spatula Cemex System Container Shakit Cemex System Mixer MectaCem Bowl 2Mix Kyphoplasty Tool Kit InterSpace Shoulder InterSpace Tapered Wedge Stem InterSpace Hip InterSpace Knee Interspace Tapered Wedge Stem XL InterSpace Hip XL MectaCem-X HV Conflow Bone Cement Cemex Isoplastic 1/2 pack MectaCem-X LV Cemex Isoplastic Cemex RX Mendec Aqua Mendec Aqua Cartridge Mendec Spine HV System CEMENT KIT Mendec Spine HV TEKTONA HV US Bone Cement Mendec Spine Kyverment SPSCM4U U00249 SPSCM4U U00275 SPSCM4U U00291 SPSCM4U U00299 SPSCM4U U00234 SPSCM4U U00220 SPSCM4U U00240 SPSCM4U U00255 SPSCM4U U00300 InterSpace GV Hip XL Tapered Wedge Stem Interspace GV Hip Spacer InterSpace GV Hip Tapered Wedge Stem Mendec V Fill Kyphon VuE™ Bone Cement Rally All In One Cement Gun Xtruder GUN-01 Bone Injection Needles 2Mix Gun Temporary Elbow Spacer with Gentamicin & Vancomycin - custom HP Connection Tube Cannula for Knee Shoulder Cannula Hip Cannula Freezer Ring Mendec Spine Kit Rally HV Bone Cement 40 Grams Rally MV Bone Cement 40 Grams RALLY MV ALL IN ONE SYSTEM 70 GRAMS RALLY HV ALL IN ONE SYSTEM 70 GRAMS Cemex Genta Cemex Genta System Cemex System Genta Fast Conflow G Bone Cement MectaCem-X LV with Gentamicin MectaCem-X HV with Gentamicin InterSpace Tapered Wedge Stem Trial InterSpace Hip Trial InterSpace Shoulder Trial InterSpace Knee ATS Trial Kit InterSpace Hip Trial XL InterSpace Knee Trial XL InterSpace Knee Trial Interspace Hip Tapered Wedge Stem Trial InterSpace Tapered Wedge Stem Trial XL Interspace GV Hip Trial Cemex System 80 g Cemex System 60 g InterSpace Knee ATS InterSpace Knee (XL size) Cemex Prep Kit cement restrictor MectaCem Bone Prep Balloon Inflator

    Establishment Types

    Manufacture Medical Device Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device for Another Party (Contract Manufacturer)