FDA Registration
Active
🇬🇧 United Kingdom
STERIGENICS UK LIMITED
Reg #: 3015219237
·
FEI: 3015219237
·
Expires 2026
Products
35
Proprietary Names
404
Establishment Types
1
Classifications
35
Registration Details
- Registration Name
- STERIGENICS UK LIMITED
- Registration Number
- 3015219237
- FEI Number
- 3015219237
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Unit 3a, Seymour Link Road
- City
- Chesterfield Derbyshire
- Country
- GB
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 | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Instrument, Biopsy | KNW | Class 2 | Gastroenterology, Urology | No | 2013-02-26 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2012-12-03 |
| Arthroscope | HRX | Class 2 | Orthopedic | No | 2012-12-03 |
| Needle, Aspiration And Injection, Disposable | GAA | Class 1 | General, Plastic Surgery | No | 2012-11-01 |
| Bone Cement, Antibiotic | MBB | Class 2 | Orthopedic | No | 2013-01-31 |
| Bone Cement | LOD | Class 2 | Orthopedic | No | 2013-01-31 |
| Endoscopic Access Overtube, Gastroenterology-Urology | FED | Class 2 | Gastroenterology, Urology | No | 2024-08-09 |
| Negative Pressure Wound Therapy Powered Suction Pump | OMP | Class 2 | General, Plastic Surgery | No | 2025-07-15 |
| Hysteroscope (And Accessories) | HIH | Class 2 | Obstetrics/Gynecology | No | 2012-12-03 |
| Bag, Intestine | KGY | Class 1 | General, Plastic Surgery | No | 2017-06-20 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2019-07-01 |
| Mixer, Cement, For Clinical Use | JDZ | Class 1 | Orthopedic | No | 2012-10-29 |
| Apparatus, Autotransfusion | CAC | Class 2 | Anesthesiology | No | 2021-03-05 |
| Dispenser, Cement | KIH | Class 1 | Orthopedic | No | 2012-11-01 |
| Dressing, Wound, Occlusive | NAD | Class 1 | General, Plastic Surgery | No | 2012-12-19 |
| Hemostatic Wound Dressing Without Thrombin Or Other Biologics | QSY | Class U | Unknown | No | 2021-03-05 |
| Tubing, Pressure And Accessories | BYX | Class 1 | Anesthesiology | No | 2012-12-14 |
| Pump, Air, Non-Manual, For Endoscope | FEQ | Class 2 | Gastroenterology, Urology | No | 2021-03-05 |
| Filler, Bone Void, Calcium Compound | MQV | Class 2 | Orthopedic | No | 2019-07-01 |
| Tubing/Tubing With Filter, Insufflation, Laparoscopic | NKC | Class 1 | Obstetrics/Gynecology | No | 2019-07-02 |
| Dish, Tissue Culture | KIZ | Class 1 | Hematology | No | 2012-11-01 |
| Dressing, Wound, Drug | FRO | Class U | Unknown | No | 2022-08-31 |
| Dissector, Surgical, General & Plastic Surgery | GDI | Class 1 | General, Plastic Surgery | No | 2012-11-01 |
| Bone Cement, Posterior Screw Augmentation | PML | Class 2 | Orthopedic | No | 2025-06-27 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2025-06-27 |
| Dressing, Wound, Hydrophilic | NAC | Class 1 | General, Plastic Surgery | No | 2013-02-04 |
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2019-07-02 |
| Laparoscope, Gynecologic (And Accessories) | HET | Class 2 | Obstetrics/Gynecology | No | 2019-07-02 |
| Instrument, Compression | HWN | Class 1 | Orthopedic | No | 2024-05-07 |
| Applicator, Ent | KCJ | Class 1 | Ear, Nose, Throat | No | 2012-11-06 |
| Anti Fog Solution And Accessories, Endoscopy | OCT | Class 2 | Gastroenterology, Urology | No | 2019-07-02 |
| Nasal Spray, Ent Delivery | KCO | Class 1 | Ear, Nose, Throat | No | 2024-05-01 |
| Apparatus, Suction, Single Patient Use, Portable, Nonpowered | GCY | Class 1 | General, Plastic Surgery | No | 2012-10-23 |
| Curette | HTF | Class 1 | General, Plastic Surgery | No | 2019-10-21 |
| Bone Grafting Material, Synthetic | LYC | Class 2 | Dental | No | 2019-07-01 |
Proprietary Names
Enspire Vacuum Tubing Cassette
Enspire Vacuum and Rinse Tubing Cassette
VAPR® Temperature Control End Effect Electrode 2.3 mm x 140 mm
Electrosurgical cutting and coagulation device and accessories VAPR TC ELECTRODE
11 guage Bone Access Needles
Homer Breast Localization Needles
OnPharma OnSet Cartridge Connector
MiniStop Plus
BackStop Plus
Monoject Bone Marrow Biopsy Tray with Safety Components
PERCUCUT NEEDLES, N105, N110, N115, N710, N715, N810, N815
Turkel Safety Fluid Drainage System
Curity Amniocentesis Tray
Disposable Needles
BONE BIOPSY NEEDLE
Curity Thoracentesis Trays with Safety Components
Facet Screw Instruments
FNA - Fine Needle Aspiration
CHIBA NEEDLE
MEDTRONIC Facet Screw Instruments
Turkel Thoracentesis System: 566059
Turkel Thoracentesis System: 566034
Integra; Jarit; MicroFrance; Miltex; Padgett; Xomed
Anesthesia Peribulbar; Retrobulbar Needles
Turkel Thoracentesis System: 566075
Monoject Sternal-lliac Aspiration Needle
Turkel Safety Thoracentesis Procedural Tray
Monoject Basic Bone Marrow Biopsy and Aspiration Tray with Safety Components
Monoject Bone Marrow Biopsy and Aspiration Tray with Safety Components
Monoject Basic Bone Marrow Biopsy Tray with Safety Components
Monoject Bone Marrow Biopsy Prepping Tray with Safety Components
Monoject Bone Marrow Biopsy / Aspiration Needle
Cardinal blunt fill needle with filter
Temporary Sharps Holder "ShortStopGrandstand
Cardinal blunt fill needle wwithout filter
545050501 SmartSet GMV Gentamicin Bone Cement
40g SmartSet GMV Gentamicin Bone Cement
545050500 SmartSet GMV Endurance Gentamicin Bone Cement
GMV EO US Bone Cement
VAPR® 2.3 End Effect Electrode 140mm
20g SmartSet MV Bone Cement
SmartSet MV Bone Cement
40g SmartSet MV Bone Cement
ActiVAC, 5 Pack
Hysteroscope (And Accessories) TWIZZLE ELECTRODE (5 PACK)
Versapoint Bipolar Electrode - Spring Tip 5 Fr. (1.6 mm nom.) x 360 mm
Versapoint Bipolar Electrode - Twizzle Tip 5 Fr. (1.6 mm nom.) x 360 mm
Hysteroscope (And Accessories) SPRING ELECTRODE (5 PACK)
Hysteroscope (And Accessories) BALL ELECTRODE (5 PACK)
INTESTINE BAG
Organ Bag
10GA EnCor
10GA EnCor MRI Blunt Tip
10GA EnCor Upright
10GA EnCor MRI
Rinse Tube, VS3000
Tissue Collection Tray, 10G, 7G, MR
Needle Guide Insert, 10G, Lorad
Needle Guide Insert, Aurora, EnCor MRI
EnCor Needle Guide Insert 7 Gauge
EnCor Syringe Adapter
Collection Tray Cover
EnCor Needle Guide Insert 12 Gauge
Needle Guide Insert, Lorad
EnCor Needle Guide Insert 10 Gauge
Needle Guide Insert, 12G, Fischer
Tissue Collection Tray, 7G
General Surgical Instrument
ER2 Saturate Mixing System
VORTEX & MIXOR NOZZLE UMBRELLA
VORTEX ADAPTER
VORTEX VACUUM MIXING SYSTEM
VACUUM TUBE W/SUC BYPASS
VORTEX & MIXOR NOZZLE ANGLED
VORTEX VACUUM BOWL
VORTEX&MIXOR NZLE STAND BRKAWY
MIXOR FEMORAL PRESSURIZER-LG
KYPHON® Mixer
VORTEX RE-USE KIT
VORTEX & MIXOR NOZZLE REVISION
VORTEX&MIXOR NZLE LONG TAPERED
0206-548-000
0206-547-000
0206-556-000
0206-566-000
0206-545-000
0206-546-000
0206-509-000;0206-564-000
HiVac Bowl Bone Cement Mixing System B713
0506-482-000
0605-685-015
0606-573-000
0606-583-000
0306-564-000
0606-705-000
0506-689-015
0605-683-015
0606-595-000
0506-486-000
0606-509-000
MiniMix LV Bone Cement Mixing System SMLV
0605-687-015
0605-887-000
0506-685-015
0606-516-000
Medium Port MiniMix Bone Cement Mixing System SMMM1
RALLY Vacuum Mixing Bowl 7127-1801
0506-483-000
Mixing Bowl, Spatula B710
0606-593-000
0606-515-000
0606-517-000
0606-514-000
0707-001-000 AutoPlex M4 Cement Mixer
0506-489-000
0606-553-000S1
Kyphon Mixer
0606-705-000S1
0306-553-000S2
0506-485-000
0606-512-000
0606-593-000S1
0606-565-000
0506-686-015
0606-520-000
0506-683-015
0506-682-015
0606-518-000
0606-553-000
0606-563-000
0306-563-000
0306-573-000
0506-687-015
CellTrans Post-Operative Autotransfusion System
90 Degree Breakaway Nozzle
INTRODIGITATOR
CDrive Cement Dispenser
CDrive Cartridge Assembly
KYPHON® Directional Bone Filler Device
JET-VAC CEM DISP INT TIP
KYPHON® Cement Delivery System
Kyphon Bone Filler Device
Kyphon Cement Delivery System
Kyphon Bone Filler Devices
FEMORAL PRESSURIZER
Cement dispenser
KYPHON® Bone Filler Devices
HiVac Syringe Bone Cement Mixing and Delivery System
MiniMix Delivery Syringe SMDS1C
ZIMMER BONE CEMENT INJECTOR
ZIMMER CEMENT DISPENS
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
Electrosurgical cutting and coagulation device and accessories VAPRFLEX END EFFECT (FLEX END EFFECT)
Electrosurgical cutting and coagulation device and accessories THERMAFLEX SIDE EFFECT (FLEX THERMAL SIDE EFFECT)
Electrosurgical cutting and coagulation device and accessories ANGLED END
VAPR® Angled End Effect Electrode 3.5 mm x 160 mm
VAPR® Side Effect Electrode 3.5 mm x 160 mm
VAPR® Flexible End Effect Electrode 3.5 mm x 160 mm
VAPR® 90 Degree Hook Electrode 3.5 mm x 160 mm
VAPR® Flexible Side Effect Electrode 3.5 mm x 160 mm
VAPR® Angled Side Effect Electrode 3.5 mm x 160 mm
VAPR® End Effect Electrode 3.5 mm x 160 mm
Electrosurgical cutting and coagulation device and accessories HOOK (90 DEG HOOK)
Electrosurgical cutting and coagulation device and accessories ANGLED SIDE
Electrosurgical cutting and coagulation device and accessories SIDE EFFECT
Electrosurgical cutting and coagulation device and accessories VAPRFLEX SIDE EFFECT (FLEX SIDE EFFECT)
Electrosurgical cutting and coagulation device and accessories THERMAFLEX END EFFECT (FLEX THERMAL END EFFECT)
Electrosurgical cutting and coagulation device and accessories END EFFECT
VAPR® COOLPULSE® Curve XL Suction Electrode Curved Suction Electrode with Integrated Handpiece and Hand Controls 200mm
VAPR® TRIPOLAR 90° Suction Electrode 90° Suction with Integrated Handpiece and Hand Controls
VAPR® COOLPULSE® Curve Suction Electrode Curved Suction Electrode with Integrated Handpiece and Hand Controls 135mm
Dish, Tissue Culture
17240/48
17651/100
PETRI60X15/100
Slide Permanox
384 Shallow Well, Standard Height, CC Black
Italy Nunclon OmniTray Barcode
Pre-Assembled CF-10 w/TS
Novartis 992, 384W Plate, w/BC
384 Shallow Well, Standard Height, CC White
384 Well, White, CC Treat
Skin Graft Growth Dish
1536 Shallow Well, Standard HT CC Black, w/Lid
Cell Factory 1 Chamber 632 CM2
225cm2 Easy Flask, Vent
384 Well, Black, CC Treat
1536 Shallow Well, Standard HT CC White, w/Lid
1536 Shallow Well, Standard HT CC Clear, w/Lid
Barcoded 384W OBP, Black, CC, GSK
384 OBP, Black, CC Treat, w/Lid
Cell Fact 10 Chamber 6,320 CM2
384 OBP Coverglass, Black, CC, w/Lid
150x15mm TC Dish w/Vents
384 Shallow Well, Standard Height, CC Clear
384 OBP Coverglass, Black, CC, w/Lid Sample
Cell Factory 10 Chamber 6,320 CM2
225cm2 Easy Flask, Filter
384 Well, Clear, CC Treat
Omnitray, CC Treat, Ster, w/Lid
EasyFill CF Adapt Port Cap, ½
35 x 10mm Suspension Dish
96 Well OBP, TCC, Black
Pre-Assembled CF-40, Novartis
EasyFill CF ¼
4 Well Dish Nunclon Strl, Lid
35 x 10mm TC Dish w/2mm Grid
EasyFill, CF 3/8
Cell Factory 2 Chamber 1,264 CM2
384 Well Plate, PS, White w/o lid, CC treated
CelBio, OmniTray, Nunclon,n D-BC-S1&2
384 Well Plate, Black w/o Lid
Cell Factory 40 Chamber 25, 280cm
Skin Graft Growth Dish with Lifter
384 OBP, Black, CC Treat, w/o Lid
384 White CC w/2 barcode labels
96 OBP Polymer Black CC w/Lid
384 Well Plate w/barcode labels
8 Well Dish Nunclon Stel, Lid
60 x 15mm TC Dish Permanox
96 OBP Polymer White CC w/Lid
60g SmartMix Cemvac prefilled with SmartSet HV Bone Cement,
80g SmartMix Cemvac prefilled with SmartSet HV Bone Cement,
SmartMix Cemvac with SmartSet HV Bone Cement
Medtronic Instrument
Confidence High Viscosity Spinal Cement
AQUACEL Foam
Super absorbent woven Eclypse Adherent Sacral
Foam/silicone Advazorb Silflo/Silflo Lite
Foam/silicone Advazorb/Advazorb Lite (Advazorb Plus)
Super absorbent woven dressing Eclypse Boot
Woven Eclypse
Woven Ecylpse Adherent
Mepore Pro / Ultra
Foam/silicone Advazorb Silfix/Silfix Lite
Non woven ribbon dressing Advadraw Spiral
Non woven dressing Advadraw
Dressing, Wound Hydrophilie
Triad
Foam Wound Dressings - 004766,004781,004782,003900, 003901,003902,003903,003904, 001502,001042, 005085
Zetuvit (plus)
Advazorb Fixation
Advadraw
Zorflex ZF20
Zorflex ZF10
Eclypse Contour
Zetuvit Plus Silicone (Border)
Advazorb Heel
Eclypse Adherent
Advazorb Sacral
Zorflex ZF15
Advazorb Areola
Advadraw Spiral
Advazorb
Eclypse Foot
Advazorb Silfix
Eclypse Boot
Eclypse Border & Border Oval
Advazorb Border Lite
Eclypse
Advazorb Border
Eclypse Adherent Sacral
ConvaFoam Border
ConvaFoam Non-Adhesive
AQUACEL Foam Pro
ConvaFoam Silicone
Exufiber
SmartSet HV Bone Cement
20g SmartSet HV Bone Cement
40g SmartSet HV Bone Cement
Femoral Cement Pressuriser P721
3312040 DePuy CMW 1 Bone Cement
3322020 DePuy CMW 2 Bone Cement
3312020 DePuy CMW 1 Bone Cement
3332040 DePuy CMW 3 Bone Cement
3322040 DePuy CMW 2 Bone Cement
DePuy CMW 1 Bone Cement
SmartSet MV Endurance Bone Cement
3332020 DePuy CMW 3 Bone Cement
DePuy 3 CMW Bone Cement
DePuy CMW 3 Bone Cement
Electrosurgical cutting and coagulation device and accessories ELECTRODE, PK SUPERSECT (ANGLED LOOP)
PLASMAKINETIC SUPERPULSE SYSTEM SuperLoop PK Front Loading Electrode
PLASMAKINETIC SUPERPULSE SYSTEM SuperSect PK Front Loading Electrode
Electrosurgical cutting and coagulation device and accessories ELECTRODE, PK SUPERSECT (90° LOOP)
7GA EnCor MRI
7GA EnCor
7GA EnCor Upright
12GA EnCor Probe Upright
12GA EnCor
EnCor /VisilocMRI Introducer
NasaMist saline Spray
Granufoam Medium Dressing, 5 Pack
Granufoam Medium Dressing, 10 Pack
3315020 DePuy CMW 1 Gentamicin Bone Cement
DePuy CMW 1 Gentamicin Bone Cement
545031500 DePuy CMW 1 Gentamicin Bone Cement
Jackson-Pratt Wound Drainage Devices
TRU-CLOSE Suction Drainage System
Suction Reservoir Kit
3335020 DePuy CMW 3 Gentamicin Bone Cement
545033500 DePuy CMW 3 Gentamicin Bone Cement
545032500 DePuy CMW 2 Gentamicin Bone Cement
DePuy CMW 2 Gentamicin Bone Cement
DePuy CMW 3 Gentamicin Bone Cement
3325040 DePuy CMW 2 Gentamicin Bone Cement
Electrosurgical cutting and coagulation device and accessories RD SHORT SIDE ELECTRODE (2.3 VAPR SIDE EFFECT (SHORT))
VAPR® 2.3 Side Effect Electrode 140mm
VAPR® 2.3 Side Effect Electrode (Short) 85 mm
Electrosurgical cutting and coagulation device and accessories RD SIDE ELECTRODE (2.3 VAPR SIDE EFFECT)
VAPR® ARCTIC Suction Electrode Dome Tip with Integrated Handpiece
VAPR® ARCTIC Suction Electrode Chisel Tip with Integrated Handpiece
Electrosurgical cutting and coagulation device and accessories RD SHORT WEDGE (2.3mm WEDGE (SHORT))
Electrosurgical cutting and coagulation device and accessories RD STANDARD WEDGE 2.3mm WEDGE
VAPR® 2.3 Wedge Electrode 140mm
VAPR® 2.3 Wedge Electrode (Short) 85 mm
InfoVAC with Gel, 10 Pack
InfoVAC without Gel, 10 Pack
INFOVAC CAN ASSY, W/O GEL, 5 PK
INFOVAC CAN ASSY, W/ GEL, 10 PK
INFOVAC CAN ASSY, W/O GEL, 10 PK
V.A.C. WhiteFoam Dressings
Curette
Electrosurgical cutting and coagulation device and accessories THERMAL ANGLED END (VAPR T THERMAL ANGLED END)
Electrosurgical cutting and coagulation device and accessories THERMAL SIDE
Electrosurgical cutting and coagulation device and accessories THERMAL REV ANGLED SIDE (VAPR T THERMAL REV ANGLED SIDE)
Suprasorb A+Ag
Supreme Ag
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)