Sterigenics Denmark A/S

FDA Device Registration & Listing · Espergaerde Sjalland, DK · Registration 3006405073

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3006405073
FEI Number
3006405073
Entity Name
Sterigenics Denmark A/S
City/State/Country
Espergaerde Sjalland, DK
Establishment Address
Aa Louis - Hansens Alle 11, Espergaerde Sjalland DK-3060, DK
Establishment Type(s)
Sterilize Medical Device for Another Party (Contract Sterilizer)
Owner / Operator
Sotera Health LLC (Owner Number: 10029425)
Owner / Operator Contact Address
2015 Spring Road, Suite 650, Oak Brook, IL 60523, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Gold Anchor SpeediCath Compact Male Kit Gold Anchor 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 Gold Anchor 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 Gold Anchor 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¿

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
IYE Accelerator, Linear, Medical Radiology Class 2 892.5050 2020-12-08
EZD Catheter, Straight Gastroenterology, Urology Class 2 876.5130 2025-01-06
IYE Accelerator, Linear, Medical Radiology Class 2 892.5050 2020-12-08
FRO Dressing, Wound, Drug Unknown Class U N/A 2025-01-06
DXC Clamp, Vascular Cardiovascular Class 2 870.4450 2012-12-04
MQK Labware, Assisted Reproduction Obstetrics/Gynecology Class 2 884.6160 2020-03-23
LXB Hearing Aid, Bone Conduction Ear, Nose, Throat Class 2 874.3302 2024-01-11
PUC Microtools, Assisted Reproduction (Pipettes), Exempt Obstetrics/Gynecology Class 2 884.6130 2023-10-31
FAQ Bag, Urine Collection, Leg, For External Use, Sterile Gastroenterology, Urology Class 1 876.5250 2012-12-12
GBM Catheter, Urethral Gastroenterology, Urology Class 2 876.5130 2025-01-06
ELR Post, Root Canal Dental Class 1 872.3810 2021-09-17
LXB Hearing Aid, Bone Conduction Ear, Nose, Throat Class 2 874.3302 2024-01-11
MAH Hearing Aid, Bone Conduction, Implanted Ear, Nose, Throat Class 2 874.3302 2024-01-11
MAH Hearing Aid, Bone Conduction, Implanted Ear, Nose, Throat Class 2 874.3302 2025-01-06
FZE Prosthesis, Nose, Internal General, Plastic Surgery Class 2 878.3680 2024-01-11
MQK Labware, Assisted Reproduction Obstetrics/Gynecology Class 2 884.6160 2020-03-23
MAH Hearing Aid, Bone Conduction, Implanted Ear, Nose, Throat Class 2 874.3302 2020-03-23
PFO Active Implantable Bone Conduction Hearing System Ear, Nose, Throat Class 2 874.3340 2024-01-11
LMF Agent, Absorbable Hemostatic, Collagen Based General, Plastic Surgery Class 3 878.4490 2023-10-31
IYE Accelerator, Linear, Medical Radiology Class 2 892.5050 2013-02-05
GBM Catheter, Urethral Gastroenterology, Urology Class 2 876.5130 2022-09-19
MTX Microscope And Microscope Accessories, Reproduction, Assisted Obstetrics/Gynecology Class 1 884.6190 2013-02-05
MQG Accessory, Assisted Reproduction Obstetrics/Gynecology Class 2 884.6120 2013-02-05
MQK Labware, Assisted Reproduction Obstetrics/Gynecology Class 2 884.6160 2013-02-05
LXB Hearing Aid, Bone Conduction Ear, Nose, Throat Class 2 874.3302 2024-01-11
LXB Hearing Aid, Bone Conduction Ear, Nose, Throat Class 2 874.3302 2020-03-23
MQK Labware, Assisted Reproduction Obstetrics/Gynecology Class 2 884.6160 2020-03-23
LRC Instrument, Ent Manual Surgical Ear, Nose, Throat Class 1 874.4420 2012-11-14
MQE Needle, Assisted Reproduction Obstetrics/Gynecology Class 2 884.6100 2020-03-06
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2023-10-31
LXB Hearing Aid, Bone Conduction Ear, Nose, Throat Class 2 874.3302 2024-01-11
EZD Catheter, Straight Gastroenterology, Urology Class 2 876.5130 2025-01-06
MQK Labware, Assisted Reproduction Obstetrics/Gynecology Class 2 884.6160 2017-03-22
FRO Dressing, Wound, Drug Unknown Class U N/A 2013-01-06
LGZ Warmer, Thermal, Infusion Fluid General Hospital Class 2 880.5725 2025-01-15
BSB Warmer, Blood, Non-Electromagnetic Radiation Hematology Class 2 864.9205 2025-01-15
MAH Hearing Aid, Bone Conduction, Implanted Ear, Nose, Throat Class 2 874.3302 2020-03-23
MAH Hearing Aid, Bone Conduction, Implanted Ear, Nose, Throat Class 2 874.3302 2024-01-11
MAH Hearing Aid, Bone Conduction, Implanted Ear, Nose, Throat Class 2 874.3302 2020-03-23
MQE Needle, Assisted Reproduction Obstetrics/Gynecology Class 2 884.6100 2020-03-06
EZD Catheter, Straight Gastroenterology, Urology Class 2 876.5130 2025-01-06
IYE Accelerator, Linear, Medical Radiology Class 2 892.5050 2023-10-31
HIO Sampler, Amniotic Fluid (Amniocentesis Tray) Obstetrics/Gynecology Class 1 884.1550 2012-11-20
KJF System, Suspension, Cell Culture Hematology Class 1 864.2240 2012-11-01

Official Correspondent

Karen Whaley-Krumins

US Agent Details

Chris Eustace Email: ceustace@sterigenics.com Phone: (630) 9281700

Related Public Records

Same Entity

Sotera Health LLC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3005914490 UNIDADE DE ESTERILIZACAO COTIA LTDA. Cotia Sao Paulo, BR
9680579 Sterigenics Radiation Technologies Canada, Inc PORT COQUITLAM British Columbia, CA
3008132411 Sterigenics Shanghai E Beam Ltd. Shanghai, CN
9616517 Sterigenics S. de R.L. de C.V. Tepeji del Rio de Ocampos Hidalgo, MX
3008328679 Sterigenics S. de R.L. de C.V. Cuautitlan Izcalli Mexico, MX

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K071992 Varian Medical Systems HIGH-DEFINITION 120 MULTILEAF COLLIMATOR (HD120 MLC) 2007-08-15
K253962 Radformation, Inc. ClearCheck (RADCC V2.7) 2026-04-03
K003779 Arplay Medical S.A. IMMOBILIZATION SYSTEM FOR ENT 2001-07-12
K150256 Argentum Medical SILVERLON BURN CONTACT DRESSINGS 2015-04-30
K143738 Intuit Medical Products, LLC DSS Sinusplasty Balloon Catheter 2015-08-27

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0004-2019 Varian Medical Systems 2
TrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy Delivery System version 2.0 and 2.5 Product Usage: The TrueBeam delivery systems are intended to provide radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
Z-0005-2019 Varian Medical Systems 2
VitalBeam Radiotherapy Delivery System Version 2.5 Product Usage: The VitalBeam delivery systems are intended to provide precision radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
Z-0020-2015 N/A 2
Proteus 235 Proton Therapy System for cancer treatment.
Z-0035-2012 Accuray Incorporated 2
CyberKnife Robotic Radiosurgery System, Synchrony Respiratory Tracking System (Standard Treatment Couch). Synchrony Respiratory Tracking System, a Radiation Therapy Device, Model Numbers: 026429, 028185. Product is manufactured and distributed by Accuray, Inc., Sunnyvale, CA
Z-0036-2012 Accuray Incorporated 2
CyberKnife Robotic Radiosurgery System, Synchrony Respiratory Tracking System (Robocouch Patient Positioning System), a Radiation Therapy Device. Model Numbers: 026430, 028186. Product is manufactured and distributed by Accuray, Inc., Sunnyvale, CA

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006405073. Last updated year: 2026. Please use registration number 3006405073 when referencing this establishment in official correspondence.
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