BEUDAMED
    FDA Registration Active 🇩🇰 Denmark

    Sterigenics Denmark A/S

    Reg #: 3006405073 · FEI: 3006405073 · Expires 2026
    View on FDA
    Products
    26
    Proprietary Names
    126
    Establishment Types
    1
    Classifications
    26

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    Registration Details

    Registration Name
    Sterigenics Denmark A/S
    Registration Number
    3006405073
    FEI Number
    3006405073
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Aa Louis - Hansens Alle 11
    City
    Espergaerde Sjalland
    Country
    DK

    Owner / Operator

    Firm Name
    Sotera Health LLC
    Operator Number
    10029425
    Address
    2015 Spring Road, Suite 650
    City
    Oak Brook
    State
    IL
    Postal Code
    60523
    Country
    US
    Correspondent
    Karen Whaley-Krumins

    Products

    Device Name Product Code
    Accelerator, Linear, Medical IYE
    Catheter, Straight EZD
    Dressing, Wound, Drug FRO
    Clamp, Vascular DXC
    Labware, Assisted Reproduction MQK
    Hearing Aid, Bone Conduction LXB
    Microtools, Assisted Reproduction (Pipettes), Exempt PUC
    Bag, Urine Collection, Leg, For External Use, Sterile FAQ
    Catheter, Urethral GBM
    Post, Root Canal ELR
    Hearing Aid, Bone Conduction, Implanted MAH
    Prosthesis, Nose, Internal FZE
    Active Implantable Bone Conduction Hearing System PFO
    Agent, Absorbable Hemostatic, Collagen Based LMF
    Microscope And Microscope Accessories, Reproduction, Assisted MTX
    Accessory, Assisted Reproduction MQG
    Instrument, Ent Manual Surgical LRC
    Needle, Assisted Reproduction MQE
    Implant, Endosseous, Root-Form DZE
    Warmer, Thermal, Infusion Fluid LGZ
    Warmer, Blood, Non-Electromagnetic Radiation BSB
    Sampler, Amniotic Fluid (Amniocentesis Tray) HIO
    System, Suspension, Cell Culture KJF
    Collector, Ostomy EXB
    Dressing, Wound, Occlusive NAD
    Neurological Stereotaxic Instrument HAW

    Proprietary Names

    Gold Anchor SpeediCath Compact Male Kit Biatain Ag Adhesive Biatain Ag Non-Adhesive Microwell group culture dish, 16-well Microwell group culture dish, 9-well Micropipettes, glass Micromanipulation pipettes MEDICAL DEVICES INTERNATIONAL (MDI)- Drainage Bags Drainage Bag Extension Tubing MEDICAL DEVICES INTERNATIONAL Conveen Contour Conveen Security+ SpeediCath Compact Set female Surtex Sterile Posts Embryoslide+ culture dish Radiotherapy gold marker Gold Anchor SpeediCath accessories SpeediCath Standard with Accessories SpeediCath Standard EmbryoSlide® Culture Dish Embryoslide culture dish Heating Tip Accutip OSI200 Implant Template Follicle Aspiration Set, Reduced Single Lumen Follicle Aspiration Set, Reduced Atlas Implant Packs Speedicath Compact Female Speedicath Compact Female Plus Transducer Cover Rapid-i Kit °M WARMER SYSTEM Follicle Aspiration Set Follicle Aspiration Set, Double & Single Lumen Luja female SAMPLER, AMNIOTIC FLUID (AMNIOCENTESIS TRAY) Amniotic fluid sampler – needle for amnioscentesis AMNIOCENTESIS KIT Amnioscentesis needle Amniocentesis needle and accessories AMNIOCENTESIS TRAY(EDD)% 10/CA Portex Amniocentesis Kits EXP-Pak¿ SenSura Mio Baby SenSura drainable Assura Post Op SenSura Post Op SpeediCath Compact Set male ALLEVYN Complete Care 3"x4" Primapad Non-Adherent Dressing 3"x8" Primapad Non-Adherent Dressing Biatain CUD Film Wound Dressing Silflex DUODERM STERILE DRESSING, DUODERM STERILE DRESSING (SIGNAL HYDROACTIVE), BORDER, CG, EXTRA THIN, 2"x3" Reliamed Non-Adherent Dressing Episil Absorbent DUODERM CGF BDR DRS 15X15CM (1X5PK) NAI DUODERM CGF DRS15X20CM (1X5PK) NAI DUODERM SIGNAL 20X20CM (1X5PK) NAI DUODERM SIGNAL 15X18CM (1X5PK) NAI DUODERM XTHIN DRS OVAL (1X20PK) NAI DUODERM CGF BDR DRS 10X10CM (1X5PK) NAI DUODERM CGF DRS 20X20CM (1X5PK) NAI DUODERM SIGNAL 20X22.5CM (1X5PK) NAI DUODERM SIGNAL 14X14CM (1X5PK) NAI DUODERM SIGNAL 20X23CM (1X5PK) NAI DUODERM XTHIN DRS TRG (1X10PK) NAI DUODERM SIGNAL 18.5X19.5CM (1X5PK) NAI Bolin Chest Seal DUODERM XTHIN DRS 10X10CM (1X10PK) NAI DUODERM CGF BDR DRS 6X6CM (1X5PK) NAI DUODERM CGF DRS 15X15CM (1X20PK) NAI DUODERM XTHIN DRS 5X20CM (1X10PK) NAI DUODERM XTHIN DRS OVAL (1X10PK) NAI DUODERM SIGNAL 11X19CM (1X5PK) NAI DUODERM XTHIN DRS 7.5X7.5CM (1X20PK) NAI DUODERM CGF DRS 15X15CM (1X5PK) NAI DUODERM CGF BDR DRS 10X13CM (1X5PK) NAI DUODERM CGF DRS 10X10CM (1X5PK) NAI DUODERM CGF DRS 20X30CM (1X5PK) NAI DUODERM CGF DRS 10X10CM (1X20PK) NAI DUODERM CGF BDR DRS 15X18CM (1X5PK) NAI DUODERM XTHIN DRS 5X10CM (1X20PK) NAI DUODERM SIGNAL 10X10CM (1X5PK) NAI DUODERM XTHIN DRS 15X15CM (1X10PK) NAI DUODERM DRS 10X10CM (1X20PK) NAI Biatain Silicone ALLEVYN Gentle Stratamed StrataXRT Biatain Silicone Lite Stratacel Allevyn Life H-Vent StrataGRT NelDerm Hydrogel Dressings Derpixa StrataCTX Comfeel Plus Biatain Super Non-Adhesive Band-Aid Neutrogena Sensitive Skin Triangle Acne Patches Comfeel Plus Contour Biatain Super Adhesive Adhesive Bandage Coverlet Biatain Silicone Non-border Neutrogena Sensitive Skin Mini Acne Patches Comfeel Plus Transparent Foam Lite ConvaTec Neutrogena Sensitive Skin Blemish Patches Episil Biatain Adhesive CUD+ CTD Dressing wound occlusive Biatain Soft-Hold 2"x3" Primapad Non-Adherent Dressing Biatain Non-Adhesive Neutrogena Sensitive Skin Nose Patches Hydrocolloid adhesive bandages Compeed Neutrogena Stubborn Acne Ultra-Thin Blemish Patches Biatain Silicone Fit Luja Coude

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)