BEUDAMED
    FDA Registration Active 🇮🇪 Ireland

    Synergy Health Ireland Ltd

    Reg #: 3002807314 · FEI: 3002807314 · Expires 2026
    View on FDA
    Products
    182
    Proprietary Names
    88
    Establishment Types
    1
    Classifications
    182

    Registration Details

    Registration Name
    Synergy Health Ireland Ltd
    Registration Number
    3002807314
    FEI Number
    3002807314
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    IDA Business and Technology Park
    City
    Tullamore Offaly
    Country
    IE

    Owner / Operator

    Firm Name
    STERIS Corporation
    Operator Number
    10042227
    Address
    5960 Heisley Road
    City
    Mentor
    State
    OH
    Postal Code
    44060
    Country
    US

    US Agent

    Business Name
    Synergy Health
    Contact Name
    Becky Aldhizer
    Address
    5960 Heisley Rd
    City
    Mentor
    State
    OH
    ZIP
    44060
    Country
    US
    Email
    [email protected]
    Phone
    440 4687462

    Products

    Device Name Product Code
    Arthroscope HRX
    Catheter, Peripheral, Atherectomy MCW
    Stents, Drains And Dilators For The Biliary Ducts FGE
    Negative Pressure Wound Therapy Powered Suction Pump OMP
    Aspiration Thrombectomy Catheter QEZ
    Stent, Superficial Femoral Artery NIP
    Wire, Guide, Catheter DQX
    Tube, Bronchial (W/Wo Connector) BTS
    Stent, Colonic, Metallic, Expandable MQR
    Catheter, Continuous Flush KRA
    Bronchoscope Accessory KTI
    Device, Percutaneous Retrieval MMX
    Ureteroscope And Accessories, Flexible/Rigid FGB
    Cardiovascular Procedure Kit OEZ
    Catheter, Percutaneous DQY
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Laparoscopic Contraceptive Tubal Occlusion Device KNH
    Catheter, Angioplasty, Peripheral, Transluminal LIT
    Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented KWY
    Prosthesis, Hip, Femoral Component, Cemented, Metal JDG
    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented LZO
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented JDI
    Needle, Conduction, Anesthetic (W/Wo Introducer) BSP
    Dilator, Vessel, For Percutaneous Catheterization DRE
    Unit, Electrosurgical, Endoscopic (With Or Without Accessories) KNS
    Stent, Coronary MAF
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented LPH
    Catheter, Hemodialysis, Implanted MSD
    Mechanical Thrombolysis Catheter QEY
    Pancreatic Stent, Covered, Metallic, Removable PCU
    Filter, Infusion Line FPB
    Introducer, Catheter DYB
    Catheter, Intravascular, Diagnostic DQO
    Coronary Drug-Eluting Stent NIQ
    System, Test, Blood Glucose, Over The Counter NBW
    Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems QLG
    Endoscopic Guidewire, Gastroenterology-Urology OCY
    General Surgery Tray LRO
    Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate MEH
    Prosthesis, Hip, Hemi-, Femoral, Metal KWL
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented LWJ
    Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer KWZ
    Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass DTL
    Filler, Bone Void, Calcium Compound MQV
    Powered Laser Surgical Instrument GEX
    Filter, Intravascular, Cardiovascular DTK
    Drills, Burrs, Trephines & Accessories (Simple, Powered) HBE
    Catheter, Straight EZD
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer JWH
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive OIY
    Stent, Metallic, Expandable, Duodenal MUM
    Eye Tray OJK
    Tissue Adhesive Internal Use PLJ
    Protector, Transducer, Dialysis FIB
    Bone Cement, Antibiotic MBB
    Dressing, Wound, Hydrophilic NAC
    Instrument, Ultrasonic Surgical LFL
    Peripheral Mechanical Thrombectomy With Aspiration QEW
    Tube, Tracheal (W/Wo Connector) BTR
    Single Use Instrument Tray OJV
    Wire, Guide, Catheter, Exempt PTL
    Device, Vascular, For Promoting Embolization KRD
    Automated External Defibrillators (Non-Wearable) MKJ
    Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer MBH
    Extended Depth Of Focus Intraocular Lens POE
    Intraocular Lens HQL
    Lens, Multifocal Intraocular MFK
    Lens, Intraocular, Toric Optics MJP
    Bone Cement LOD
    Cement, Bone, Vertebroplasty NDN
    Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection GCA
    Bone Grafting Material, Synthetic LYC
    Neurological Tray OJG
    Aortic Valve, Prosthesis, Percutaneously Delivered NPT
    Catheter, Coronary, Atherectomy MCX
    Stent, Carotid NIM
    Mitral Valve Repair Devices NKM
    Set, Administration, Intravascular FPA
    Light Source, Fiberoptic, Routine FCW
    Light, Catheter, Fiberoptic, Glass, Ureteral FCS
    Stent, Iliac NIO
    Endovascular Suturing System OTD
    Prosthesis, Tracheal, Expandable JCT
    Syringe, Balloon Inflation MAV
    Catheters, Transluminal Coronary Angioplasty, Percutaneous LOX
    Catheter, Ureteral, Gastro-Urology EYB
    Dispenser, Cement KIH
    Tubes, Gastrointestinal (And Accessories) KNT
    Wax, Bone MTJ
    Angiography/Angioplasty Kit OEQ
    Dermatome GFD
    Endoscopic Irrigation/Suction System OCX
    Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation OAE
    Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days FOZ
    Obstetrical Kit OKV
    Catheter, Nephrostomy LJE
    Accessories, Catheter, G-U KNY
    Stylet For Catheter, Gastro-Urology EZB
    Stent, Ureteral FAD
    Dilator, Catheter, Ureteral EZN
    Dilator, Esophageal KNQ
    Prosthesis, Esophageal ESW
    Biopsy Needle FCG
    Stylet, Ureteral EYA
    Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated PZE
    Accelerator, Linear, Medical IYE
    Iliac Covered Stent, Arterial PRL
    Temporary Carotid Catheter For Embolic Capture NTE
    Injector, Vertebroplasty (Does Not Contain Cement) OAR
    Attachment, Breathing, Positive End Expiratory Pressure BYE
    Device, Hemostasis, Vascular MGB
    Filter, Conduction, Anesthetic BSN
    Tube Tracheostomy And Tube Cuff JOH
    Endoscopic Ultrasound System, Gastroenterology-Urology ODG
    Methyl Methacrylate For Cranioplasty GXP
    Instrument, Manual, General Obstetric-Gynecologic KOH
    Catheter, Thrombus Retriever NRY
    Intracranial Neurovascular Stent NJE
    Ablation Catheter, Renal Denervation QYI
    Pulmonary Valve Prosthesis Percutaneously Delivered NPV
    Endoscope Channel Accessory ODC
    Biliary Stent System For Benign Strictures PNB
    Dislodger, Stone, Biliary LQR
    Integrated Continuous Glucose Monitoring System, Factory Calibrated QBJ
    Catheter, Steerable DRA
    Catheter For Crossing Total Occlusions PDU
    Catheter, Percutaneous, Cutting/Scoring PNO
    System, Photopheresis, Extracorporeal LNR
    Pacemaker/Icd/Crt Non-Implanted Components OSR
    Leadless Pacemaker PNJ
    Drug-Eluting Peripheral Transluminal Angioplasty Catheter ONU
    Tube, Double Lumen For Intestinal Decompression And/Or Intubation FEG
    Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring NWX
    Stent, Renal NIN
    Catheter, Flow Directed DYG
    Coronary Covered Stent NIV
    Catheter, Intravascular Occluding, Temporary MJN
    Tissue Adhesive For The Topical Approximation Of Skin MPN
    Prosthesis, Mitral Valve, Percutaneously Delivered NPU
    Syringe, Balloon Inflation, Exempt PTM
    System, Endovascular Graft, Aortic Aneurysm Treatment MIH
    Injector, Contrast Medium, Automatic IZQ
    Bronchial Thermoplasty System OOY
    Shunt, Portosystemic, Endoprosthesis MIR
    Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection NFA
    System, Appendage Closure, Left Atrial NGV
    Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed OTO
    Stylet, Surgical, General & Plastic Surgery GAH
    Snare, Non-Electrical FGX
    Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece ERL
    Dressing, Wound, Occlusive NAD
    Sensor, Glucose, Invasive MDS
    Needle, Biopsy, Cardiovascular DWO
    Staple, Fixation, Bone JDR
    Agents, Embolic, For Treatment Of Uterine Fibroids NAJ
    Implantable Cardioverter Defibrillator (Non-Crt) LWS
    Permanent Defibrillator Electrodes NVY
    Dressing, Wound, Drug FRO
    Stent, Iliac Vein QAN
    Hydrogel Spacer OVB
    Snare, Flexible FDI
    Laparoscope, General & Plastic Surgery GCJ
    Catheter, Percutaneous, Neurovasculature QJP
    Forceps, Biopsy, Non-Electric FCL
    Stent, Superficial Femoral Artery, Drug-Eluting NIU
    Dilator, Urethral KOE
    System, Balloon, Intra-Aortic And Control DSP
    Dislodger, Stone, Basket, Ureteral, Metal FFL
    Cannula, Surgical, General & Plastic Surgery GEA
    Stent, Central Venous QKJ
    Needle, Aspiration And Injection, Disposable GAA
    Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous MBL
    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish MAY
    Needle, Catheter GCB
    Stent, Urethral, Prostatic, Permanent Or Semi-Permanent MER
    Bit, Drill HTW
    Cuff, Nerve JXI
    Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter OAD
    Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation QZI
    Colonoscope And Accessories, Flexible/Rigid FDF
    Duodenoscope And Accessories, Flexible/Rigid FDT
    Kidney Perfusion Kit PIN

    Proprietary Names

    Harmac2308 (TL) - Avance Solo NPWT System LakeRegion8374 (TH,TL) - Lake Region Axessio Stryker10080 (TL) - Exeter X3 RimFit Cup Zimmer (WP) - LONGEVITY IT HIGHLY CROSSLINKED POLYETHYENE LINERS Creagh8289 (TL) - First Choice Creagh8289 (TL) - Advance Serenity™ 18 Hollister (BT) - Vapro Plus Hollister (BT) - Vapro Plus Pocket Hollister (TL) - VaPro Pocket Zimmer (TL) - PERSONA® Revision Knee System Molnlycke (KK,VL) - Lyofoam Max FirstWater14138 (RG) - DUP86266-9 - Xtrasorb Foam Adhesive Molnlycke (KK,VL) - Lyofoam Dressings FirstWater14138 (RG) - DUP86144-9 - Xtrasorb Foam Non- Adhesive FirstWater14138 (RG) - DUP86233-9 - Xtrasorb Foam Adhesive FirstWater14138 (RG) - DUP86122-9 - Xtrasorb Foam Non- Adhesive AdvMed8429 (BF) - "McKesson Calcium Alginate Dressing FirstWater14138 (RG) - DUP86244-9 - Xtrasorb Foam Adhesive FirstWater14138 (RG) - DUP86188-9 - Xtrasorb Foam Non- Adhesive StrykerIreland (TL) - 12cm iQ Micro StrykerIreland (TL) - 12cm iQ Barracuda StrykerIreland (TL) - 18cm iQ Apex Micro Claw StrykerIreland (TL) - 12cm iQ Micro Claw StrykerIreland (TL) - 12cm iQ Claw StrykerIreland (TL) - 12cm iQ 120 Claw StrykerIreland (TL) - 20cm iQ Standard StrykerIreland (TL) - 12cm iQ Apex 360 StrykerIreland (TL) - 20cm iQ Apex 360 StrykerIreland (TL) - 11cm iQ Apex Knife StrykerIreland (TL) - 12cm iQ Large StrykerIreland (TL) -10cm iQ Broad Knife StrykerIreland (TL) - 11cm iQ Knife StrykerIreland (TL) - 12cm iQ Serrated Large StrykerIreland (TL) - 18cm iQ Micro Claw StrykerIreland (TL) - 12cm iQ Standard Crega6530 (TH) - GORE® DrySeal Flex Introducer Sheath Zimmer (TL) - Persona Vit E Poly Articular Blocks (MC) Edwards10187 (TL) - PASCAL Precision Transcatheter Valve Repair System Creagh8289 (TL) - Sublime Microcatheter Summit8301 (DV) - HiVac7 Bone Cement Mixing and Delivery System (Triple application) C703 Summit8301 (DV) - HiVac7 with Femoral Cement Pressuriser CP701 Summit8301 (DV) - 9mm Nozzle with Nozzle Extruder Escoffier11264 (MC) - DISPENSER, CEMENT Creagh8289 (TL) - Sublime™ 014 Rx PTA Balloon Dilatation Catheter Creagh8289 (TL) - Biotronik Passeo-35 HP StrykerIreland (TL) - 37cm iQ Large Arrotek8349 (TL) - LiquID 061 Guide Catheter Extension BSCI (KK,TL) - SYNERGY MEGATRON Everolimus-Eluting Platinum Chromium Coronary Stent System BSCI (KK,TL) - SYNERGY XD Everolimus-Eluting Platinum Chromium Coronary Stent System BSCI (KK,TL) - SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System Neuravi11842 (TL) - EMBOTRAP III Revascularization Device Medtronic8444 (TL) - Symplicity Spyral™ Renal Denervation System Edwards10187 (TL) - Edwards Commander Delivery System Zimmer (TL,DK) - Persona TM Porous Natural Tibia, Vivacit -E Patella and Articular Surfaces BSCI (TL) - Ranger Perfuze (VL) - Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set Teleflex (TL) - Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set BSCI (TL) - SMARTFREEZE Catheter Extension Cable SMARTFREEZE Cryo-Cable BSCI (TL) - POLARx FIT Cryoablation Balloon Catheter [Short Tip (ST)] POLARx FIT Cryoablation Balloon Catheter [Long Tip BSCI (TL) - POLARx Cryoablation Balloon Catheter [Short Tip (ST)] POLARx Cryoablation Balloon Catheter [Long Tip (LT)] AlconLabs9477 (TL,TH) - AutonoMe Automated Pre- loaded Delivery System PACAT0 AlconLabs9477 (TL,TH) - AutonoMe Automated Pre- loaded Delivery System PXCAT0 AutonoMeTM Automated Pre- loaded Delivery System (CCATT3-T6) AlconLabs9477 (TL,TH) - AutonoMe Automated Pre- loaded Delivery System CNAET0 AlconLabs9477 (TL,TH) - AutonoMe Automated Pre- loaded Delivery System CCAET3-T6 AlconLabs9477 (TL,TH) - AutonoMe Automated Pre- loaded Delivery System PACAT3-T6 AlconLabs9477 (TL,TH) - AutonoMe Automated Pre-loaded Delivery System PXYAT3-T6 AlconLabs9477 (TL,TH) - AutonoMe Automated Pre-loaded Delivery System PAYAT3-T6 AlconLabs9477 (TL,TH) - AutonoMe Automated Pre- loaded Delivery System CCAET0 Arrotek8349 (TL) - LiquID 51 LP Guide Catheter Extension Creagh8289 (TL) - Advance Serenity™ 14 Zimmer (WP) - Continuum And Trilogy Integrated Taper (IT) Acetabular Systems Edwards10187 (TL) - Edwards eSheath Introducer Set and Edwards eSheath+ introducer set Neuravi11842 (TL) - EMBOGUARD Balloon Guide Catheter Zimmer (TL,DK) - Persona Knee System-CPS Creagh8289 (TL) - Sublime™ Radial Access Guide Sheath Purfuze12609 (TL) - Zipline Access Catheter MeritIreland10054 (TL) - Go2Wire Guide Wire Medtronic8444 (TL) - Harmony DCS Jabil8683 (DK) - CONFIDENCE Spinal Cement System Harmac2308 (TL) - Foam Wound Dressing Creagh8289 (TL) - Sublime™ Radial Access 018 RX PTA Dilatation Catheter Newclip11561 (MS) - BIT, DRILL PBC9955 (TL) - ReFeel LakeRegion8374 (TH,TL) - Lake Region NorthStar Guidewire Idoman10039 (TL) - GTS DUAL BLUE TUBING SET Idoman10039 (TL) - GTS DUAL RED TUBNG SET Creagh8289 (TL) - GORE Molding Occlusion Balloon Catheter

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)