BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    Synergy Health Radeberg GMBH

    Reg #: 3008102042 · FEI: 3002924544 · Expires 2026
    View on FDA
    Products
    64
    Proprietary Names
    95
    Establishment Types
    1
    Classifications
    64

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    Registration Details

    Registration Name
    Synergy Health Radeberg GMBH
    Registration Number
    3008102042
    FEI Number
    3002924544
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Juri-Gagarin-Strasse 15
    City
    Radeberg Saxony
    Country
    DE

    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
    STERIS Corporation
    Contact Name
    Becky Aldhizer
    Address
    5960 Heisley Road
    City
    Mentor
    State
    OH
    ZIP
    44060
    Country
    US
    Email
    [email protected]
    Phone
    440 4687462

    Products

    Device Name Product Code
    Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented HSD
    Shoulder Prosthesis, Reverse Configuration PHX
    Labware, Assisted Reproduction, Exempt PUD
    Rod, Fixation, Intramedullary And Accessories HSB
    Needle, Hypodermic, Single Lumen FMI
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer JWH
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented LWJ
    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented LZO
    Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer KWZ
    Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented KWY
    Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate MEH
    Abutment, Implant, Dental, Endosseous NHA
    Implant, Endosseous, Root-Form DZE
    Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented OQI
    Dressing, Wound, Hydrogel Without Drug And/Or Biologic NAE
    Screw, Fixation, Bone HWC
    Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer HSX
    System, Dialysate Delivery, Central Multiple Patient FKQ
    Agent, Absorbable Hemostatic, Collagen With Polymeric Additives SGV
    Applicator, Absorbent Tipped, Sterile KXG
    Wound Dressing With Animal-Derived Material(S) KGN
    Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented KWT
    Unit, Phacofragmentation HQC
    Eye Tray OJK
    Hook, Ophthalmic HNQ
    Shunt, Central Nervous System And Components JXG
    Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component KTT
    Filler, Bone Void, Calcium Compound MQV
    Wire, Surgical LRN
    Plate, Fixation, Bone HRS
    Accessories, Catheter KGZ
    Device, Hemostasis, Vascular MGB
    Laparoscope, Gynecologic (And Accessories) HET
    System, Water Purification, General Medical Use NHV
    Guide, Surgical, Instrument FZX
    Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature QRK
    Cable, Electrode IKD
    Intervertebral Fusion Device With Bone Graft, Lumbar MAX
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Specula, Ophthalmic HNC
    Cannula, Ophthalmic HMX
    Device, Monitoring, Intracranial Pressure GWM
    Pin, Fixation, Smooth HTY
    Drape, Surgical, Exempt PUI
    Probe, Radiofrequency Lesion GXI
    Catheter, Straight EZD
    Orthosis, Spondylolisthesis Spinal Fixation MNH
    Orthosis, Spinal Pedicle Fixation MNI
    Thoracolumbosacral Pedicle Screw System NKB
    Motor, Surgical Instrument, Ac-Powered GEY
    Scalpel, One-Piece GDX
    Forceps, Ophthalmic HNR
    Orthopedic Manual Surgical Instrument LXH
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented JDI
    Electrode, Depth GZL
    Fastener, Fixation, Biodegradable, Soft Tissue MAI
    Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature FMK
    Dialyzer, High Permeability With Or Without Sealed Dialysate System KDI
    Spatula, Ophthalmic HND
    Dressing, Wound, Hydrophilic NAC
    Dressing, Wound, Occlusive NAD
    Ventilator, Continuous, Facility Use CBK
    Gastrointestinal Tubes With Enteral Specific Connectors PIF
    Catheter, Urethral GBM

    Proprietary Names

    Implantcast (RB) - AGILON XO Shoulder Replacement System BirrBio12027 (ED,RB) - ART Labware Implantcast (RB) - MK femoral spacer distal ll/rm incl. screw Implantcast (RB) - ACS® LD PS femoral component cemented Implantcast (RB) - screw for MK spacer Implantcast (RB) - ACS® LD FB+ Tibia cemented incl. plugs Implantcast (RB) - ACS® LD extension stem male taper Implantcast (RB) - MK femoral spacer posterior incl. screw Implantcast (RB) - ACS® stem Implantcast (RB) - ACS® LD femoral component cemented Implantcast (RB) - MK femoral spacer distal rl/lm incl. screw Implantcast (RB) - ACS® double taper Implantcast (RB) - ACS® FB screw for tibial spacer Implantcast (RB) - ACS® LD SC femoral component cemented Implantcast (RB) - ACS® FB tibial spacer lateral incl. screw DOT (RB) - Z1 Hip System DOT (RB) - Surgikor Dental Implant System Implantcast (RB) - ic-head CoCrMo 36 mm Implantcast (RB) - ic-head Bioloxdelta FirstWater14138 (RG,SE) - Medela Breast Pads (USA) FirstWater14138 (RG) - 73230-02 - Leukomed Control Sterile FirstWater14138 (RG) - 73230-03 - Leukomed Control Sterile FirstWater14138 (RG) - DUP86466-9 - Xtrasorb HCS Adhesive FirstWater14138 (RG) - Russell Chest Seal FirstWater14138 (RG) - DUP86322-9 Xtrasorb HCS FirstWater14138 (RG) - 73230-05 - Leukomed Control Sterile FirstWater14138 (RG) - CWL 1008 - KerraLite Cool Border FirstWater14138 (RG) - CWL 1005 - KerraLite Cool FirstWater14138 (RG) - Curad “Soothe & Cool” Dressing (56 x 26mm) FirstWater14138 (RG) - CWL 1009 - KerraLite Cool Border FirstWater14138 (RG) - 6030-4156 - Glaciergel FirstWater14138 (RG) - CWL 1004 - KerraLite Cool FirstWater14138 (RG) - 73230-00 - Leukomed Control Sterile FirstWater14138 (RG) - CVS86433-9 Xtrasorb HCS Non- Adhesive 3""x3"" (cvs) FirstWater14138 (RG) - 40-2979 - Hydrogel Dressing FirstWater14138 (RG) - DUP86344 - Xtrasorb HCS 4.5" X 4.5" FirstWater14138 (RG) - DUP86388-9 - Xtrasorb HCS Non- Adhesive FirstWater14138 (RG) - 6030-4157 - Glaciergel FirstWater14138 (RG) - 73230-01 - Leukomed Control Sterile FirstWater14138 (RG) - Curad “Soothe & Cool” Dressing (74 x 45mm) FirstWater14138 (RG) - CWL 1007 - KerraLite Cool Border FirstWater14138 (RG) - CWL 1006 - KerraLite Cool Implantcast (RB) - MUTARS® femoral stem cemented Implantcast (RB) - ACS LD Uni FB Knee System GattTech (RB) - ETHIZIA™ Hemostatic Patch 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 Medskin (RB) - MatriDerm pluS+ Bi-Layer Implantcast (RB) - Actinia® hip stems Implantcast (RB) - AGILON® XO Shoulder Replacement System MedSkin (RB) - MatriDerm SteriPack9541 (RB) - Celt ACD5F, Celt ACD6F, Celt ACD7F SteripacGmbH (RB) - Celt ACD®5F, Celt ACD®6F, Celt ACD®7F Newclip11561 (MS) - Soft tissues protector SteripackPoland (RB) - AVS A-LAT PEEK SPACERS, MODELS 48750XXX, 48751XXX, 48752XXX, 48753XXX Kuros12218 (RB) - MagnetOs Flex Matrix Implantcast (RB) - EcoFit® short stem cementless cpTi Implantcast (RB) - MUTARS femoral stem cemented BVI8325 (RG) - SPECULUM BLADED BVI8325 (RG) - LASIK CANNULA (DAYA) D.O.R.C. (VL1) - Backflush instrument DORC10527 (VL1) - Cannula, Ophthalmic CHMuller (RB) - Loop-X Disposable Sterile Drape Set Colplast1941 (RB) - SpeediCath Compact Female Colplast1941 (RB) - SpeediCath Compact Plus SteripackPoland (RB) - Mantis Spinal System DeSoutter8410 (DV) - Passing Pin DeSoutter8410 (DV,RG) - Stericut StrykerTrauma (RB) - Scalpel DORC10527 (VL1) - Forceps, Ophthalmic 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; Implantcast (RB) - implaFit® Hip Stem Implantcast (RB) - AGILON® metaphyseal component trauma incl. safety screw MedSkin (RB) - MagnetOs-Flex-Matrix Implantcast (RB) - MUTARS Proximal Femur Replacement System BlinkMedical8355 (TH) - Surgical Manipulation Instruments DORC10527 (VL1) - Spatula, Ophthalmic 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 Colplast1941 (RB) - SpeediCath Standard Male Colplast1941 (VL1) - SpeediCath Accessories

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)