BEUDAMED
    FDA Registration Active 🇮🇹 Italy

    STERIS SPA

    Reg #: 3002806603 · FEI: 3002806603 · Expires 2026
    View on FDA
    Products
    83
    Proprietary Names
    203
    Establishment Types
    1
    Classifications
    83

    Registration Details

    Registration Name
    STERIS SPA
    Registration Number
    3002806603
    FEI Number
    3002806603
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    3, 5, 7, 9, VIA EINAUDI
    City
    CALCINATE Bergamo
    Country
    IT

    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
    Catheter, Angioplasty, Peripheral, Transluminal LIT
    Catheter, Percutaneous DQY
    Injector, Contrast Medium, Automatic IZQ
    Filter, Blood, Cardiopulmonary Bypass, Arterial Line DTM
    Heat-Exchanger, Cardiopulmonary Bypass DTR
    Oxygenator, Cardiopulmonary Bypass DTZ
    Reservoir, Blood, Cardiopulmonary Bypass DTN
    Pacemaker/Icd/Crt Non-Implanted Components OSR
    Implantable Pacemaker Pulse-Generator DXY
    Defibrillator, Implantable, Dual-Chamber MRM
    Implantable Cardioverter Defibrillator (Non-Crt) LWS
    Cement, Bone, Vertebroplasty NDN
    Thoracolumbosacral Pedicle Screw System NKB
    Bone Cement LOD
    Bone Cement, Posterior Screw Augmentation PML
    Needle, Aspiration And Injection, Disposable GAA
    Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer HRY
    Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer MBH
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer JWH
    System, Gastrointestinal Motility (Electrical) FFX
    Radiographic Protective Glove IWP
    Pulse Generator, Permanent, Implantable NVZ
    Implantable Pulse Generator, Pacemaker (Non-Crt) LWP
    Device, Cystometric, Hydraulic FEN
    Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) KWA
    Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented KWS
    Arthroscope HRX
    Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented MBF
    Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented KWT
    Shoulder Prosthesis, Reverse Configuration PHX
    Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented KWY
    Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer KWZ
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented LPH
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented JDI
    Shield, Protective, Personnel KPY
    Powered Laser Surgical Instrument GEX
    Medical Glove, Specialty LZC
    Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System ONB
    Laparoscope, General & Plastic Surgery GCJ
    Surgeon'S Gloves KGO
    Device, Percutaneous, Biopsy MJG
    Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented PAO
    Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days FOZ
    General Surgery Tray LRO
    Apparatus, Suction, Single Patient Use, Portable, Nonpowered GCY
    Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use LXG
    Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented HSD
    Biopsy Needle FCG
    Instrument, Biopsy KNW
    Catheter, Conduction, Anesthetic BSO
    Mesh, Surgical, Polymeric FTL
    Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous MBL
    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented LZO
    Heart-Valve, Non-Allograft Tissue LWR
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented LWJ
    Set, Administration, Intravascular FPA
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Temporary Carotid Catheter For Embolic Capture NTE
    Brush, Scrub, Operating-Room GEC
    Orthopedic Manual Surgical Instrument LXH
    Brace, Drill HXY
    Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained PKC
    Cystometer, Electrical Recording EXQ
    Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) NIK
    Mixer, Cement, For Clinical Use JDZ
    Injector, Vertebroplasty (Does Not Contain Cement) OAR
    Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented OQG
    Applicator, Absorbent Tipped, Sterile KXG
    Electrode, Cortical GYC
    Hood, Surgical FXY
    Prosthesis, Elbow, Semi-Constrained, Cemented JDB
    Prosthesis, Elbow, Constrained, Cemented JDC
    Spinal Channeling Instrument, Vertebroplasty OCJ
    Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes NVN
    Dressing, Wound, Occlusive NAD
    Gown, Surgical FYA
    Drill, Bone, Powered DZI
    Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment HWE
    Instrument, Surgical, Sonic And Accessory/Attachment JDX
    Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece ERL
    Drills, Burrs, Trephines & Accessories (Simple, Powered) HBE
    Condenser, Heat And Moisture (Artificial Nose) BYD
    Guide, Needle, Surgical GDF

    Proprietary Names

    Ulrich (CC) - ulricheasyINJECT Max Microport (CC) - PLATINIUM DR 1510 Microport (CC) - PLATINIUM VR 1240 Microport (CC) - PLATINIUM DR 1540 Microport (CC) - PLATINIUM VR 1210 Jabil8683 (DK) - CONFIDENCE Spinal Cement System LimaCorpSPA9283 (CC,SR) - Physica system LimaCorpSPA9283 (CC) - Physica system Microport (CC) - ALIZEA SR 1300 Microport (CC) - CELEA SR 1100 Microport (CC) - CELEA DR 1400 Microport (CC) - ESPRIT SR Microport (CC) - REPLY DR Microport (CC) - ESPRIT DR Microport (CC) - REPLY SR Microport (CC) - Accessory for pacemaker, ICD and CRT-D Screw driver Microport (CC) - ALIZEA DR 1600 LimaCorpSPA9283 (CC) - CMD 24-1336 ProMade Hip LimaCorpSPA9283 (CC) - CMD 24-1494 ProMade Hip LimaCorpSPA9283 (CC) - CMD 24-1278 ProMade Hip LimaCorpSPA9283 (CC) - CMD 24-1568 ProMade Hip LimaCorpSPA9283 (CC) - CMD 24-1298 ProMade Hip LimaCorpSPA9283 (CC) - CMD 24-1441 ProMade Hip LimaCorpSPA9283 (CC) - CMD 24-1396 ProMade Hip LimaCorpSPA9283 (CC) - CMD 24-1417 ProMade Hip LimaCorpSPA9283 (CC) - CMD 24-1454 Promade Hip LimaCorpSPA9283 (CC) - CMD 24-1439 Promade Hip LimaCorpSPA9283 (CC) - CMD 24-1434 ProMade Hip LimaCorpSPA9283 (CC) - CMD 24-1137 ProMade Hip LimaCorpSPA9283 (CC) - CMD 24-1491 ProMade Hip LimaCorpSPA9283 (CC) - CMD 24-1586 ProMade Hip LimaCorpSPA9283 (CC) - SMR 3-Pegs Small LimaCorpSPA9283 (CC) - SMR 3-Pegs Standard LimaCorpSPA9283 (CC,SR) - SMR TT Augmented Glenoid System LimaCorpSPA9283 (CC, SR) - Cemented cups; Lock Bipolar heads; Modular heads; Modulus femoral stems LimaCorpSPA9283 (CC,SR) - Physica KR knee system LimaCorpSPA9283 (CC) - SMR Modular Glenoid Quanta (CC) - EMP-FBX200BHS, EMP-FBX200BHS-C Quanta (CC) - EMP-FBX200HS, EMP-FBX272HS, EMP-FBX365HS, EMP-FBX550HS, EMP-FBX1000HS, EMP-FBX272HS-C Quanta (CC) - EMP-FBX200HR, EMP-FBX272HR, EMP-FBX365HR, EMP-FBX550HR, EMP-FBX1000HR, EMP-FBX272HR-C Ulrich (CC) - ulrichINJECT CT motion LimaCorpSPA9283 (CC,SR) - Bone screws 5mm LimaCorpSPA9283 (CC) - CMD 24-1584 ProMade Hip LimaCorpSPA9283 (CC) - CMD 25-1137 ProMade Hip LimaCorpSPA9283 (CC) - CMD 25-1207 ProMade Hip LimaCorpSPA9283 (CC) - CMD 25-1075 ProMade Hip LimaCorpSPA9283 (CC) - CMD 25-1271 ProMade Hip LimaCorpSPA9283 (CC) - CMD 25-1238 ProMade Hip LimaCorpSPA9283 (CC) - CMD 25-1131 ProMade Hip LimaCorpSPA9283 (CC) - CMD 25-1446 ProMade Hip LimaCorpSPA9283 (CC) - CMD 24-1603 ProMade Hip LimaCorpSPA9283 (CC) - CMD 25-1053 ProMade Hip LimaCorpSPA9283 (CC) - CMD 25-1362 ProMade Hip LimaCorpSPA9283 (CC) - CMD 25-1008 ProMade Hip LimaCorpSPA9283 (CC) - CMD 25-1228 ProMade Hip LimaCorpSPA9283 (CC) - CMD 25-1416 ProMade Hip LimaCorpSPA9283 (CC) - CMD 24-1641 ProMade Hip LimaCorpSPA9283 (CC) - CMD 25-1402 ProMade Hip LimaCorpSPA9283 (CC) - CMD 24-1610 ProMade Hip LimaCorpSPA9283 (CC) - CMD 25-1313 ProMade Hip LimaCorpSPA9283 (CC) - CMD 25-1081 ProMade Hip LimaCorpSPA9283 (CC) - CMD 25-1083 ProMade Hip LimaCorpSPA9283 (CC) - SMR Reverse Liner Stirilab11801 (VB) - EQUIPMENT, LABORATORY, GENERAL PURPOSE, LABELED OR PROMOTED FOR A SPECIFIC MEDICAL USE LimaCorpSPA9283 (CC,SR) - SMR Shoulder System Sterylab (CC) - MRX-Mammorep XJ Sterylab (CC) - CCH-Complete Chiba Sterylab (CC) - FLP-Full-opty Sterylab (CC) - R-MLC1825 Sterylab (CC) - SPG-Spring-cut Sterylab (CC) - VCS-needle set Sterylab (CC) - R-BEN1110 Sterylab (CC) - MRZ-Mammorep Zeta Sterylab (CC) - CCH-CompleteChiba Sterylab (CC) - R-MLC1415 Sterylab (CC) - MRN-Mammorep Sterylab (CC) -MCN-MieloCan Sterylab (CC) - BSL-Best Lisa needles Sterylab (CC) - ATA-CUT Sterylab (CC) - MRZ-MammorepZeta Sterylab (CC) - BEST-BTT Sterylab (CC) - MCN-Mielocan Sterylab (CC) - R-FSC1825B Sterylab (CC) - ECX-Echochiba Sterylab (CC) - R-ACG1411 Sterylab (CC) - BEN-Bone Marrow needle Sterylab (CC) -MAMMOREP-LOOP Sterylab (CC) - R-MLC1820 Sterylab (CC) - FSC-FAST CUT Sterylab (CC) - R-MCN22 Sterylab (CC) - R-FSC1820B Sterylab (CC) -MLC-MultiCore Sterylab (CC) - CLT-Colt Sterylab (CC) - R-MRN2115 Sterylab (CC) -MRN-Mammorep Sterylab (CC) - BIO-CUT Sterylab (CC) - VCS-Needle set Sterylab (CC) - FSC-Fast Cut Sterylab (CC) - R-MRN2109 Sterylab (CC) - AGO-GUIDA Sterylab (CC) - PAG-Paragon Sterylab (CC) - R-MRN2106 Sterylab (CC) - R-CLT1411 Sterylab (CC) -MRX-Mammorep XJ Sterylab (CC) - SPG-SpringCut Sterylab (CC) - FLP-Full Opty Sterylab (CC) - R-AGC1411 Sterylab (CC) - BEST Sterylab (CC) - R-MRN2111 Sterylab (CC) - MLC-Multicore Sterylab (CC) - R-MLC1411 Sterylab (CC) - HEPA-CUT Quanta (CC) - OAF006011, OAF008001, OFA008011, OAF009901, OAF009911, OAF102791, OAF402011, OAF402711 Quanta (CC) - OAF002011, OAF002701, OAF002711, OAF003601, OAF003611, OAF005501, OAF005511, OAF006001 Quanta (CC) - OAF302711, OAF302721 Quanta (CC) - OAF002001 Quanta (CC) - OAF702701, OAF702711, OAF702791 Quanta (CC) - OAF103611 Quanta (CC) - OAF103691, OAF102711, Quanta (CC) - OAF703601, OAF703611, OAF703691 Plan1Health (CC) - PAINfusor catheter LimaCorpSPA9283 (CC,SR) - Minima S System Corcym (CC) - Single Use MICS Accessory Kit Corcym (CC) -Dual MICS Holder Corcym (CC) - Perceval RelyON PAK accessories kit Corcym (CC) - Single Use Accessory Kit Corcym (CC) - Dual Holder Corcym (CC) -Dual Collapser Corcym (CC) - Post-dilation Catheter LimaCorpSPA9283 (CC) - CMD 24-1393 ProMade Hip LimaCorpSPA9283 (SR,CC) - C2 Femoral Stem LimaCorpSPA9283 (SR,CC) - Delta Dual Mobility System LimaCorpSPA9283 (CC) - ProMade Shoulder; CMD 25-1253 ProMade Shoulder; CMD 25-1274 ProMade Shoulder; CMD 25-1336 LimaCorpSPA9283 (CC) - ProMade Shoulder; CMD 25-1223 ProMade Shoulder; CMD 25-1233 ProMade Shoulder; CMD 25-1248 LimaCorpSPA9283 (CC) - CMD 24-1132 Promade Shoulder LimaCorpSPA9283 (CC) - ProMade Shoulder; CMD 24-1456 ProMade Shoulder; CMD 24-1457 ProMade Shoulder; CMD 24-1470 LimaCorpSPA9283 (CC) - ProMade Shoulder; CMD 24-1375 ProMade Shoulder; CMD 24-1380 ProMade Shoulder; CMD 24-1410 LimaCorpSPA9283 (CC) - ProMade Shoulder; CMD 24-1616 ProMade Shoulder; CMD 24-1620 ProMade Shoulder; CMD 24-1629 LimaCorpSPA9283 (CC) -CMD 24-1132 Promade Shoulder; CMD 24-1224 ProMade Shoulder; CMD 24-1240 ProMade Shoulder; CMD 24-1 LimaCorpSPA9283 (CC) - ProMade Shoulder; CMD 24-1542 ProMade Shoulder; CMD 24-1556 ProMade Shoulder; CMD 24-1592 LimaCorpSPA9283 (CC) - ProMade Shoulder; CMD 24-1481 ProMade Shoulder; CMD 24-1486 ProMade Shoulder; CMD 24-1509 LimaCorpSPA9283 (CC) - ProMade Shoulder; CMD 25-1165 ProMade Shoulder; CMD 25-1176 ProMade Shoulder; CMD 25-1217 LimaCorpSPA9283 (CC) -ProMade Shoulder; CMD 24-1423 ProMade Shoulder; CMD 24-1429 ProMade Shoulder; CMD 24-1446 LimaCorpSPA9283 (CC) - ProMade Shoulder; CMD 25-1136 ProMade Shoulder; CMD 25-1151 ProMade Shoulder; CMD 25-1164 LimaCorpSPA9283 (CC) - ProMade Shoulder; CMD 25-1024 ProMade Shoulder; CMD 25-1038 ProMade Shoulder; CMD 25-1042 ProMade LimaCorpSPA9283 (CC) -ProMade Shoulder; CMD 25-1079 ProMade Shoulder; CMD 25-1110 ProMade Shoulder; CMD 25-1111 LimaCorpSPA9283 (CC) - CMD 24-1240 ProMade Shoulder Lisi34951 (ED) - MULTIPLE ORTHOPED. MANUAL INSTRUMEN Noraker11562 (MS) - ARTHREX QUICKSET DELIVERING GUN; GRAFTYS QUICKSET DELIVERING GUN Newclip11561 (MS) - Activ pins; ACTIVE Ankle pins; ACTIVE Ankle rescue kit; ACTIVE Ankle template; Alians Fragment Spec Newclip11561 (MS) - Foot & Hand Motion screw spatula; Footmotion pin; HTO pin; Large screw pins Shoulder pins Newclip11561 (MS) - Clavicle Plate pins; Clavicle Template for KIT; Distal Radius fast drilling handle; Distal Radius pi Newclip11561 (MS) - Distal Radius Plate template; Distal Radius rescue kit; Elbow pin; Foot & Hand Motion Pins; Lima9283 (CC,SR) - Prima TT Glenoid LimaCorpSPA9283 (CC) - LimaCorpSPA9283 LimaCorpSPA9283 (CC) - Revision Femoral Head LimaCorpSPA9283 (CC,SR) - PRIMA Humeral System LimaCorpSPA9283 (CC,SR) - SMR Lateralized connectors with screws Lima9283 (CC,SR) - SMR Stemless Anatomic LimaCorpSPA9283 (CC) - Physica CR Knee System LimaCorpSPA9283 (CC) - SMR 3-Pegs Glenoids LimaCorpSPA9283 (CC,SR) - Delta Liners; Delta TT Cups Microport (CC) - PLATINIUM CRT-D 1711 Microport (CC) - PLATINIUM CRT-D 1741 Microport (CC) - PLATINIUM 4LV CRT-D 1744 Summit (DV) - Medium Port MiniMix Bone Cement Mixing System SMMM1 Summit8301 (DV) - Mixing Bowl, Spatula B710 Summit8301(DV) - HiVac Bowl Bone Cement Mixing System B713 LimaCorpSPA9283 (CC,SR) - Delta TT Pro LimaCorpSPA9283 (CC,SR) - Revision Bone Screw LimaCorpSPA9283 (CC,SR) - Bone Screw LimaCorpSPA9283 (CC,SR) - Locking Bone Screw Hemodia (CC) - DOUBLEFLO LimaCorpSPA9283 (CC) - PRIMA TT Glenoid LimaCorpSPA9283 (SR) - PRIMA Humeral System; PRIMA TT Glenoid Quanta (CC) - OAF506011, OAF506001, OAF506091 Quanta (CC) - OFA001511 LimaCorpSPA9283 (CC,SR) - Revision Femoral Stem LimaCorpSPA9283 (CC) - Physica System Rover35148 (VL) - Rovers Anex Brush SteripackPoland (RB,DK,VL2,) - Sterile Flocked Swab; Sterile Foam Swab; SteriPack Sterile Polyester Spun Swab and Swab SteriPack9541 (RB,DK,VL2) - Sterile Polyester Spun Swab Rover35148 (VL) - Rovers Evalyn Brush TotalHealth (CC) - ViVi Hood LimaCorpSPA9283 (CC,SR) - TEMA Elbow system LimaCorpSPA9283 (CC,SR) - SMR Hybrid Glenoid System LimaCorpSPA9283 (CC,SR) - TEMA Elbow System LimaCorpSPA9283 (SR,CC) - Bone Screws 6.5mm LimaCorpSPA9283 (CC) - SMR TT Augmented Glenoid System Microport (CC) - Stylet Kit 45cm for VEGA R45 Microport (CC) - Stylet Kit 52cm for VEGA R52 Microport (CC) - VEGA R52 Microport (CC) - VEGA R45 Microport (CC) - Stylet Kit 58cm for VEGA R58 Microport (CC) - VEGA R58 Quanta (CC) - OAF102713, OAF102793, OAF103613, OAF103693, Quanta (CC) - OAF006003, OAF006013, OAF008003, OAF008013, OAF009903, OAF009913, OAF402013, OAF402713 Quanta (CC) - OAF002012, OAF703612, Quanta (CC) - OAF009912, OAF008012, OAF005512, OAF002712, OAF402012, OAF402712 Quanta (CC) - OAF702703, OAF702793, OAF703603, OAF703613, OAF703693 Quanta (CC) - OAF002003, OAF002013, OAF002703, OAF002713, OAF003603, OAF003613, OAF005503, OAF005513, LimaCorpSPA9283 (CC,SR) - SMR 40mm Glenosphere LimaCorpSPA9283 (CC,SR) - Physica PS Knee System

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)