BEUDAMED
    FDA Registration Active 🇫🇷 France

    IONISOS

    Reg #: 3010178296 · FEI: 3003110073 · Expires 2026
    View on FDA
    Products
    84
    Proprietary Names
    156
    Establishment Types
    1
    Classifications
    84

    Registration Details

    Registration Name
    IONISOS
    Registration Number
    3010178296
    FEI Number
    3003110073
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Parc Dombes Cotiere Activites
    City
    Dagneux Ain
    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, Shoulder, Hemi-, Humeral, Metallic Uncemented HSD
    Cement Obturator LZN
    Shoulder Prosthesis, Reverse Configuration PHX
    Posterior Cervical Screw System NKG
    Appliance, Fixation, Spinal Interlaminal KWP
    Screw, Fixation, Bone HWC
    Intervertebral Fusion Device With Bone Graft, Cervical ODP
    Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented KWS
    Appliance, Fixation, Spinal Intervertebral Body KWQ
    Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented KWT
    Prosthesis, Elbow, Constrained, Cemented JDC
    Prosthesis, Elbow, Semi-Constrained, Cemented JDB
    Spinous Process Plate PEK
    Orthosis, Spondylolisthesis Spinal Fixation MNH
    Orthosis, Spinal Pedicle Fixation MNI
    In Situ Polymerizing Peripheral Nerve Repair Device SFD
    Bone Grafting Material, Animal Source NPM
    Platelet And Plasma Separator For Bone Graft Handling ORG
    Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented KWY
    Prosthesis, Hip, Hemi-, Femoral, Metal KWL
    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, Constrained, Cemented Or Uncemented, Metal/Polymer KWZ
    Intervertebral Fusion Device With Bone Graft, Lumbar MAX
    Dressing, Wound, Drug FRO
    Cement, Bone, Vertebroplasty NDN
    Pin, Fixation, Threaded JDW
    Pin, Fixation, Smooth HTY
    Subsystem, Water Purification FIP
    Intervertebral Fusion Device With Integrated Fixation, Cervical OVE
    Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained PKC
    Thoracolumbosacral Pedicle Screw System NKB
    Mesh, Surgical, Non-Absorbable, Large Abdominal Wall Defects OXJ
    Mesh, Surgical, Polymeric FTL
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented JDI
    Prosthesis, Intervertebral Disc MJO
    Mesh, Surgical FTM
    Rod, Fixation, Intramedullary And Accessories HSB
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer JWH
    Orthopedic Manual Surgical Instrument LXH
    Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment HWE
    Staple, Fixation, Bone JDR
    Intervertebral Fusion Device With Integrated Fixation, Lumbar OVD
    Mesh, Surgical, Collagen, Large Abdominal Wall Defects OXK
    Device, Vascular, For Promoting Embolization KRD
    Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator OTN
    Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented OQG
    Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented OQI
    Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented OQH
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented LPH
    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish MAY
    Total Shoulder Arthroplasty System QHQ
    Bit, Surgical GFG
    Device, Neurovascular Embolization HCG
    Prosthesis, Elbow, Hemi-, Radial, Polymer KWI
    Prosthesis, Wrist, Carpal Trapezium KYI
    Prosthesis, Finger, Semi-Constrained, Metal/Polymer SFA
    Kit, Surgical Instrument, Disposable KDD
    Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented MBF
    Agents, Embolic, For Treatment Of Uterine Fibroids NAJ
    Implant, Endosseous, Root-Form DZE
    Abutment, Implant, Dental, Endosseous NHA
    Bit, Drill HTW
    Mesh, Surgical, For Stress Urinary Incontinence, Male OTM
    Absorbable Collagen Hemostatic Agent With Thrombin PMX
    Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component KTT
    Software For Diagnosis/Treatment OSN
    Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer HSX
    Needle, Acupuncture, Single Use MQX
    Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer KRR
    Plate, Fixation, Bone HRS
    Fastener, Fixation, Nondegradable, Soft Tissue MBI
    Mixer, Cement, For Clinical Use JDZ
    Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer HSN
    Shoulder Joint Humeral (Hemi-Shoulder) Ceramic Head/Metallic Stem Cemented Or Uncemented Prosthesis QKW
    Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis OSH
    Retractor GAD
    Instrument, Ligature Passing And Knot Tying HCF
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive OIY
    Dressing, Wound, Occlusive NAD
    Bur, Surgical, General & Plastic Surgery GFF
    Cover, Burr Hole GXR
    Dressing, Wound, Hydrophilic NAC

    Proprietary Names

    AEQUALIS RESURFACING HEAD CEMSTOP Humelock Reversed Shoulder PIT’Stop® implant I.B.S.® Osteosynthesis screw AEQUALIS REVERSED ADAPTER AEQUALIS REVERSED FX / ADAPTER AEQUALIS REVERSED II Tornier Flex Shoulder System W-Bone Wishbone HA Bionnovation Oss XB DXTEND HIGHMO PE CUP Avenir Muller Stem Ceramic Femoral Heads Exofix Opacity+ 32mm Glenosphere and Humeral Cup Ultima HA Coated Half Pins And Wire Orthex Extrenal-Fixation HA Half-Pins TOEGRIP® DIACLEAR ULTRAFILTER Easytech Anatomical Shoulder System Humeral Cup Stability AEQUALIS REVERSED FRACTURE Symbotex™ Composite Mesh CORAIL Humelock II Cementless Shoulder System ARROW Short Stem Humeral System Zimmer Biomet Ceramic Heads I.B.S.™ Osteosynthesis screw Tornier Perform Reversed MonoPost Glenoid In2Bones® Kirschner wire CEMENT RESTRICTOR MOBI-C P&F US Permacol™ Surgical Implant, 0.5mm thick ENDURAGen™ Collagen Implant ZNN CMN Nails Humeris® 135° Sholder System Avenir Complete Hip System AEQUALIS REVERSED Inflation System CoLS BROCHE 23CM 2,4MM BOUT MECHE BOUT ROND (Teknomedical) MIS II AEQUALIS GLENOID & REVERSED powered screwdrivers tips TORNIER - DRILL BIT TELEGRAPH EVOLUTION DELTA SHOULDER JARVIS Glenoid Reverse Shoulder Prosthesis Parietex™ Hydrophilic Anatomical Mesh Versatex™ Monofilament Mesh Parietex™ Hydrophilic 3-Dimensional Mesh Parietex™ Hydrophilic 2-Dimensional Mesh TRIWAY Tibiotalocalcaneal (TTC) Arthrodesis System BePOD ARTHRODESIS Parietex Composite (PCO-OS) Parietex Composite Parietex Optimized Composite Mesh (PCOX) Parietex Optimized Composite Mesh (PCO-FX) Parietex Parietex Optimized Composite Mesh (PCO-OSX) CUP HUMERALE ARROW ANATOMICAL and REVERSE Porous ARROW OS2®-VP Varisation Staple Humelock Cemented Shoulder System CORAIL2 STD SZ6 Permacol™ Surgical Implant, 1mm/1.5mm thick CoLS PEEK 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 RHS - RADIAL PROSTHESIS Glenoid Baseplate with Screw EmboCube Embolization Gelatin FX V135 Shoulder Prosthesis I-STOP Lateralized and Augmented Baseplates Biolox® delta Option Ceramic Head Biolox® delta Ceramic Head Tornier Perform Anatomic Glenoid ARROW Off-Centred Humeral Insert I.B.S.™ 2 Osteosynthesis screw Drill bits (reamer) CRF II - RADIAL PROSTHESIS BePOD PERCUTANEOUS BePOD 3A CALCANAIL Humelock II Cemented Shoulder System CMI TOUCH® CMC 1 Humeris Shoulder FX V135™ Additional Humeral Stems Neosys single use kits Neomis single use kit ( except Neomis standard UK) Duafit single use kits DUAFIT® interphalangeal implant AEQUALIS GLENOID TiN Coated Humeral Head ARROW Humeral Stem Anthogyr AXIOM® BL X3 implants Anthogyr Multi-Unit components for AXIOM® BL ARROW REVERSE shoulder long and short keel F20 Avenir Complete Hip System, Size 0 Coxa Vara I-STOP TOMS HEMOBLAST™ Bellows Laparoscopic Applicator HEMOBLAST™ Bellows DXTEND MODULAR HUM STEM DXTEND MOD EPI AEQUALIS-FRACTURE BePOD EZ WEIL ARROW ANATOMIC and REVERSE shoulder system ARROW REVERSE shoulder system axiom BL reg Talos C HA Humelock II Cemented Reversible Shoulder AEQUALIS Neofuse screws (V35, V45) Ankle Fusion Plating System (Neofuse) CORAIL REVISION STEM Quadrasphere Microspheres NOVAE dual mobility acetabular cup CoLS Fixation system Implant, endosseous, root-form BI-MENTUM dual mobility system I.B.S.® Snap-off screw OS2®-V Varisation Staple QUANTUM® Total Ankle Prosthesis PE CUP ARROW ANATOMIC shoulder system Bearing nsPVA Express AKILINK METAGLENE REVISION High V+ TiN Coated Glenosphere Parietex™ Composite Parastomal Mesh axiom BL px TIGERTRACK® EXRAY® Percutaneous Burrs Cranial LOOP (Cranial Bone Fixation System) - Neos Surgery S.L. Cinesteam® Spinefix US Novae® Dual Mobility System, Hype® Hip System axiom BL 2.8 Torpedo Gelatin Foam

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)