BEUDAMED
    FDA Registration Active 🇫🇷 France

    IONISOS

    Reg #: 3002807295 · FEI: 3002807295 · Expires 2026
    View on FDA
    Products
    36
    Proprietary Names
    62
    Establishment Types
    1
    Classifications
    36

    Registration Details

    Registration Name
    IONISOS
    Registration Number
    3002807295
    FEI Number
    3002807295
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Z.A de L Aubree
    City
    SABLE-SUR-SARTHE
    Country
    FR

    Owner / Operator

    Firm Name
    EPIONE BIDCO
    Operator Number
    10042490
    Address
    415 allee de Frenes, bat Squale
    City
    LIMONEST
    State
    Rhone
    Postal Code
    69760
    Country
    FR
    Correspondent
    Alexandra Basset

    US Agent

    Business Name
    Dawa Medical LLC
    Contact Name
    Stephan Toupin
    Address
    7320 Nw 12th St Ste 103
    City
    Miami
    State
    FL
    ZIP
    33126
    Country
    US
    Email
    [email protected]
    Phone
    786 7311159

    Products

    Device Name Product Code
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented LWJ
    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
    Prosthesis, Hip, Hemi-, Femoral, Metal KWL
    Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented KWY
    Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented KWS
    Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented HSD
    Prosthesis, Wrist, Carpal Trapezium KYI
    Prosthesis, Elbow, Semi-Constrained, Cemented JDB
    Prosthesis, Elbow, Constrained, Cemented JDC
    Mesh, Surgical, Non-Absorbable, Large Abdominal Wall Defects OXJ
    Mesh, Surgical, Polymeric FTL
    Plate, Fixation, Bone HRS
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer JWH
    Cement Obturator LZN
    Shoulder Prosthesis, Reverse Configuration PHX
    Device, Vascular, For Promoting Embolization KRD
    Prosthesis, Elbow, Hemi-, Radial, Polymer KWI
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented JDI
    Subsystem, Water Purification FIP
    Agents, Embolic, For Treatment Of Uterine Fibroids NAJ
    Pin, Fixation, Smooth HTY
    Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer HSX
    Instrument, Surgical, Non-Powered HAO
    Device, Neurovascular Embolization HCG
    Bit, Drill HTW
    Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented KWT
    Mixer, Cement, For Clinical Use JDZ
    Shoulder Joint Humeral (Hemi-Shoulder) Ceramic Head/Metallic Stem Cemented Or Uncemented Prosthesis QKW
    Rod, Fixation, Intramedullary And Accessories HSB
    In Situ Polymerizing Peripheral Nerve Repair Device SFD
    Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer KRR
    Screw, Fixation, Bone HWC
    Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component KTT
    Staple, Fixation, Bone JDR
    Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment HWE

    Proprietary Names

    CORAIL REVISION STEM CORAIL DXTEND MODULAR HUM STEM DXTEND MOD EPI CMI AEQUALIS GLENOID Symbotex™ Composite Mesh RHS - RADIAL PROSTHESIS CEMENT RESTRICTOR AEQUALIS REVERSED FRACTURE CRF II - RADIAL PROSTHESIS AEQUALIS REVERSED DXTEND HIGHMO PE CUP Versatex™ Monofilament Mesh DIACLEAR ULTRAFILTER AEQUALIS RESURFACING HEAD BI-MENTUM dual mobility system Parietex Composite (PCO-OS) Parietex Composite Parietex Optimized Composite Mesh (PCOX) Parietex Optimized Composite Mesh (PCO-FX) Parietex Parietex Optimized Composite Mesh (PCO-OSX) Parietex™ Hydrophilic 2-Dimensional Mesh Parietex™ Hydrophilic Anatomical Mesh Parietex™ Hydrophilic 3-Dimensional Mesh DELTA SHOULDER TETE HUM INOX DELT Tornier Perform Anatomic Glenoid Tornier Flex Shoulder System AEQUALIS REVERSED II AEQUALIS GLENOID & REVERSED TORNIER - DRILL BIT DXTEND GLENOSPHERE DXTEND METAGLENE DXTEND MBLOC HUM EPI DXTEND SCREW LOCK DXTEND CTA HEAD DXTEND SCREW NO LOCK DXTEND RETENT PE CUP DXTEND HUMERAL SPACER DXTEND IMP HUM CIM DXTEND STAND PE CUP EmboCube Embolization Gelatin AEQUALIS PRESS-FIT AEQUALIS-FRACTURE 611 - ANKLE FUSION NAIL Torpedo Gelatin Foam CUP HUMERALE PE CUP Parietex™ Composite Parastomal Mesh AEQUALIS Novae® Dual Mobility System, Hype® Hip System AEQUALIS REVERSED ADAPTER AEQUALIS REVERSED FX / ADAPTER CORAIL2 STD SZ6 NOVAE dual mobility acetabular cup Quadrasphere Microspheres MIS II powered screwdrivers tips Bearing nsPVA Express METAGLENE REVISION

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)