FDA Registration
Active
🇬🇧 United Kingdom
SYNERGY HEALTH STERILISATION UK LTD
Reg #: 3002807315
·
FEI: 3002807315
·
Expires 2026
Products
84
Proprietary Names
56
Establishment Types
1
Classifications
84
Registration Details
- Registration Name
- SYNERGY HEALTH STERILISATION UK LTD
- Registration Number
- 3002807315
- FEI Number
- 3002807315
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Drayton Fields Industrial Estate, Brunel Close
- City
- Daventry Northamptonshire
- Country
- GB
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 protected]
- Phone
- 440 4687462
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Protector, Ostomy | EXE | Class 1 | Gastroenterology, Urology | No | 2025-06-26 |
| Dressing, Wound, Drug | FRO | Class U | Unknown | No | 2023-02-02 |
| Instrument, Diamond, Dental | DZP | Class 1 | Dental | No | 2017-12-20 |
| Tube, Tympanostomy | ETD | Class 2 | Ear, Nose, Throat | No | 2020-12-08 |
| Tube, Smoke Removal, Endoscopic | FCZ | Class 1 | Gastroenterology, Urology | No | 2023-02-03 |
| Mesh, Surgical, Non-Absorbable, Orthopaedics, Reinforcement Of Tendon | OWX | Class 2 | General, Plastic Surgery | No | 2023-08-14 |
| Mesh, Surgical, Polymeric | FTL | Class 2 | General, Plastic Surgery | No | 2023-08-14 |
| Strip, Polishing Agent | EHM | Class 1 | Dental | No | 2017-12-20 |
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2025-11-20 |
| Filler, Bone Void, Calcium Compound | MQV | Class 2 | Orthopedic | No | 2013-03-26 |
| Splint, Intranasal Septal | LYA | Class 1 | Ear, Nose, Throat | No | 2020-12-08 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2021-06-16 |
| Catheter, Percutaneous, Cutting/Scoring | PNO | Class 2 | Cardiovascular | No | 2012-12-20 |
| Tubing/Tubing With Filter, Insufflation, Laparoscopic | NKC | Class 1 | Obstetrics/Gynecology | No | 2013-03-21 |
| Dispenser, Cement | KIH | Class 1 | Orthopedic | No | 2013-01-17 |
| Prosthesis, Hip, Hemi-, Femoral, Metal | KWL | Class 2 | Orthopedic | No | 2013-01-03 |
| Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | KWY | Class 2 | Orthopedic | No | 2013-01-03 |
| Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | MEH | Class 2 | Orthopedic | No | 2013-01-03 |
| Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component) | JDL | Class 3 | Orthopedic | No | 2013-01-03 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | JDI | Class 2 | Orthopedic | No | 2013-01-03 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish | MAY | Class 2 | Orthopedic | No | 2013-01-03 |
| Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer | KWZ | Class 2 | Orthopedic | No | 2013-01-03 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | Class 2 | Orthopedic | No | 2013-01-03 |
| Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) | KWA | Class 3 | Orthopedic | No | 2013-01-03 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2013-01-03 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | LWJ | Class 2 | Orthopedic | No | 2013-01-03 |
| Device, Monitoring, Intracranial Pressure | GWM | Class 2 | Neurology | No | 2013-12-06 |
| Needle, Hypodermic, Single Lumen | FMI | Class 2 | General Hospital | No | 2019-12-19 |
| Hook, Surgical, General & Plastic Surgery | GDG | Class 1 | General, Plastic Surgery | No | 2018-06-18 |
| Pump, Air, Non-Manual, For Endoscope | FEQ | Class 2 | Gastroenterology, Urology | No | 2013-01-21 |
| Stent, Coronary | MAF | Class 3 | Unknown | No | 2012-12-20 |
| Catheters, Transluminal Coronary Angioplasty, Percutaneous | LOX | Class 2 | Cardiovascular | No | 2012-12-20 |
| Coronary Drug-Eluting Stent | NIQ | Class 3 | Unknown | No | 2012-12-20 |
| Catheter, Angioplasty, Peripheral, Transluminal | LIT | Class 2 | Cardiovascular | No | 2012-12-20 |
| Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring | NWX | Class 3 | Unknown | No | 2012-12-20 |
| Stent, Renal | NIN | Class 3 | Unknown | No | 2012-12-20 |
| Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer | KRO | Class 2 | Orthopedic | No | 2013-01-21 |
| Mesh, Surgical, Non-Resorbable, Orthopedics, Reinforcement Of Ligament | QUW | Class 2 | General, Plastic Surgery | No | 2023-01-17 |
| Dressing, Wound, Occlusive | NAD | Class 1 | General, Plastic Surgery | No | 2012-12-20 |
| Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented | OQG | Class 2 | Orthopedic | No | 2015-08-11 |
| Agent, Absorbable Hemostatic, Collagen Based | LMF | Class 3 | General, Plastic Surgery | No | 2012-12-20 |
| Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material) | KHJ | Class 2 | Ear, Nose, Throat | No | 2013-03-15 |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | Class 2 | Radiology | No | 2013-03-05 |
| Camera, Scintillation (Gamma) | IYX | Class 1 | Radiology | No | 2013-03-05 |
| Bone Grafting Material, Synthetic | LYC | Class 2 | Dental | No | 2015-09-16 |
| Motor, Surgical Instrument, Ac-Powered | GEY | Class 1 | General, Plastic Surgery | No | 2016-11-18 |
| Mixer, Cement, For Clinical Use | JDZ | Class 1 | Orthopedic | No | 2012-12-20 |
| Wax, Bone | MTJ | Class U | Unknown | No | 2019-03-07 |
| Instrument, Ent Manual Surgical | LRC | Class 1 | Ear, Nose, Throat | No | 2013-03-15 |
| Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented | OQH | Class 2 | Orthopedic | No | 2014-12-29 |
| Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented | OQI | Class 2 | Orthopedic | No | 2014-12-29 |
| Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive | PBI | Class 2 | Orthopedic | No | 2014-12-29 |
| Washer, Bolt Nut | HTN | Class 2 | Orthopedic | No | 2013-12-13 |
| Cerclage, Fixation | JDQ | Class 2 | Orthopedic | No | 2013-12-13 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2013-12-13 |
| Pin, Fixation, Threaded | JDW | Class 2 | Orthopedic | No | 2013-12-13 |
| Pin, Fixation, Smooth | HTY | Class 2 | Orthopedic | No | 2013-12-13 |
| Tissue Adhesive For The Topical Approximation Of Skin | MPN | Class 2 | General, Plastic Surgery | No | 2015-08-26 |
| Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | ERL | Class 2 | Ear, Nose, Throat | No | 2018-07-11 |
| Curette | HTF | Class 1 | General, Plastic Surgery | No | 2022-12-24 |
| Myringotomy Procedure Kit | OGS | Class 2 | Ear, Nose, Throat | No | 2020-12-08 |
| Instrument, Compression | HWN | Class 1 | Orthopedic | No | 2017-01-20 |
| Anti Fog Solution And Accessories, Endoscopy | OCT | Class 2 | Gastroenterology, Urology | No | 2021-06-16 |
| Speculum, Ent | EPY | Class 1 | General, Plastic Surgery | No | 2015-08-25 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | Class 2 | Orthopedic | No | 2013-01-03 |
| Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer | MBV | Class 2 | Orthopedic | No | 2013-01-03 |
| Nasopharyngoscope (Flexible Or Rigid) | EOB | Class 2 | Ear, Nose, Throat | No | 2013-04-05 |
| Device, Intravascular Catheter Securement | KMK | Class 1 | General Hospital | No | 2023-12-18 |
| Unit, Filter, Membrane | JRL | Class 1 | Clinical Chemistry | No | 2015-07-22 |
| Arthroscope | HRX | Class 2 | Orthopedic | No | 2018-07-11 |
| Suture, Nonabsorbable, Synthetic, Polyethylene | GAT | Class 2 | General, Plastic Surgery | No | 2020-06-01 |
| Dressing, Wound, Hydrophilic | NAC | Class 1 | General, Plastic Surgery | No | 2012-12-20 |
| System, Water Purification, General Medical Use | NHV | Class 2 | Gastroenterology, Urology | No | 2019-03-01 |
| Passer | HWQ | Class 1 | Orthopedic | No | 2019-10-10 |
| Staple, Fixation, Bone | JDR | Class 2 | Orthopedic | No | 2013-12-05 |
| Lavage, Jet | FQH | Class 2 | General Hospital | No | 2023-08-17 |
| Probe | HXB | Class 1 | Orthopedic | No | 2020-11-30 |
| Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | FMK | Class 2 | General, Plastic Surgery | No | 2025-04-02 |
| Syringe, Piston | FMF | Class 2 | General Hospital | No | 2013-01-16 |
| Epilator, High Frequency, Needle-Type | KCW | Class 1 | General, Plastic Surgery | No | 2013-03-22 |
| Filter, Infusion Line | FPB | Class 2 | General Hospital | No | 2013-01-16 |
| Insufflator, Carbon-Dioxide, Uterotubal (And Accessories) | HES | Class 2 | Obstetrics/Gynecology | No | 2023-08-16 |
| Tubing And Tubing/Filter Fits | NVT | Class 1 | Obstetrics/Gynecology | No | 2013-01-16 |
| Laparoscope, Gynecologic (And Accessories) | HET | Class 2 | Obstetrics/Gynecology | No | 2012-12-21 |
Proprietary Names
Xiros8315 (DV) - Pitch Patch Tissue Reinforcement 30mm x 20mm. 102-1090, Pitch Patch Tissue Reinforcement 35mm x 25mm.
Surgical_Inno3346 (DV) - YelloPort Elite Single Use Seal
KeySurgical6941 (DV) - Electro Lube
Summit8301 (DV) - HiVac7 Bone Cement Mixing and Delivery System (Triple application) C703
Summit8301 (DV) - HiVac7 with Femoral Cement Pressuriser CP701
Summit8301 (DV) - 9mm Nozzle with Nozzle Extruder
Escoffier11264 (MC) - DISPENSER, CEMENT
Zimmer (DV,RG) - Taperloc Complete
Xiros8315 (DV) - CC-Hook
BlinkMedical8355 (TH) - Hook, Surgical, General & Plastic Surgery
Surgical_Inno3346 (DV,BF*) - LogiFlex Gastric Band Positioning Device
Xiros8315 (DV) - 102-1101 Infinity-Lock 5 mm x 400 mm; 102-1102 Infinity-Lock 7 mm x 400 mm
Xiros8315 (DV) -102-1082 Poly-Tape 20 mm x 800 mm; 102-1086 Poly-Tape 5 mm x 800 mm; 102-1087 Poly-Tape 7 mm x 800 mm
Xiros8315 (DV) - 102-1005 Poly-Tape 5 mm x 500 mm; 102-1080 Poly-Tape 10 mm x 800 mm; 102-1081 Poly-Tape 15 mm x 800 mm;
Xiros8315 (DV) - 10050 SIC Graft
Xiros8315 (DV) - 102-1083 Poly-Tape 30 mm x 800 mm; 102-1143 AchilloCordPLUS
DeSoutter8410 (DV) - Passing Pin
DeSoutter8410 (DV,RG) - Stericut
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
Zimmer (DV,RG,WP) - G7 OSSEOTI ACETUBLAR SHELLS
Zimmer (RG,DV) - Taperloc Complete, Size 5 And 6
Xiros8315 (DV) - Poly-Tape (102-1086, 102-1087, 102-1080, 102-1081, 102-1082) Infinity Lock (102-1100, 102-1101, 102-110
Xiros8315 (DV) - Infinity-Lock Button System
Summit8301 (DV) - Femoral Cement Pressuriser P721
KeySurgical6941 (DV) - Mr. Clear
Zimmer (DV,RG) - Vanguard SSK 360 Revision Knee System
Bedal12006 (ED,VL2) - Air S,M; Flex XS, Flex S, Bedal Flex M; Bedal PICC/CVC, PIVC, FlexGrip PICC, FlexGRIP Jr PIVC
Bedal12006 (ED,VL2) - FlexGRIP Neo Alpha; FlexGRIP Neo First; FlexGRIP Neo PIVC
Bedal12006 (ED,VL2) - NEX- Universal-CVC; 1 Drainpatch; 3 PIVC; 4 EPI/PNB, FlexGrip EPI/PNB; 5 Universal
Bedal12006 (ED,VL2) -FlexGrip Universal; FlexGRIP Alpha, FlexGRIP Foley- Universal; FlexGrip CVC; FlexGRIP Jr. PICC 2.7
Xiros8315 (DV) - Infinity-Lock 3, Infinity-Lock 5
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
Xiros8315 (DV) - FlexPasser Tendon Retrieval Kit
Xiros8315 (DV) - Poly-Tape, 30 mm x 800 mm (open weave). 102-1083
DeSoutter8410 (DV,RG) - Lavage pump kits.
DeSoutter8410 (DV,RG) - Irriagtion Kits
Xiros8315 (DV) - Rigid Probe (202-3023), Malleable Probe (202-3026)
Zimmer (DV,RG) - G7 Finned Acetabular Shell
Surgical_Inno3346 (DV,BF*) - YelloPort Plus Single Use Valves
Rocket8342 (DV) - Hysterosalpinography / Hysterosonography Catheter
Xiros8315 (DV) - TekBrace Solo, 12cm, 2470S012 TekBrace Solo, 25cm, 2470S025
Xiros8315 (DV) - Pitch Patch Tissue Reinforcement 30mm x 20mm. 102-1090, Pitch Patch Tissue Reinforcement 35mm x 25mm. 102-1
Zimmer (DV,RG) - Taperloc Complete Microplasty Stem
Zimmer (DV,RG) - G7 Freedom And Offset Liners, Freedom Head, Size 32
Surgical_Inno3346 (DV,BF*) - Logi Single Use Inserts
Xiros8315 (DV) - Fastlok
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)