FDA Registration
Active
🇬🇧 United Kingdom
Synergy Health Sterilisation UK Ltd
Reg #: 3010155648
·
FEI: 3010155648
·
Expires 2026
Products
37
Proprietary Names
19
Establishment Types
1
Classifications
37
Registration Details
- Registration Name
- Synergy Health Sterilisation UK Ltd
- Registration Number
- 3010155648
- FEI Number
- 3010155648
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Roydsdale Way
- City
- West Yorkshire Bradford
- 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 |
|---|---|---|---|---|---|
| Drills, Burrs, Trephines & Accessories (Simple, Powered) | HBE | Class 2 | Neurology | No | 2017-01-26 |
| Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | ERL | Class 2 | Ear, Nose, Throat | No | 2015-05-15 |
| Dressing, Wound, Drug | FRO | Class U | Unknown | No | 2025-09-11 |
| Bur, Dental | EJL | Class 1 | Dental | No | 2013-12-24 |
| Computer, Diagnostic, Programmable | DQK | Class 2 | Cardiovascular | No | 2025-11-20 |
| Brush, Dermabrasion, Powered | GFE | Class 1 | General, Plastic Surgery | No | 2023-12-19 |
| 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 |
| Fastener, Plate, Cranioplasty | HBW | Class 2 | Neurology | No | 2018-09-03 |
| Cover, Burr Hole | GXR | Class 2 | Neurology | No | 2018-09-03 |
| Motor, Drill, Pneumatic | HBB | Class 2 | Neurology | No | 2023-12-19 |
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2013-03-19 |
| Bur, Ear, Nose And Throat | EQJ | Class 1 | Ear, Nose, Throat | No | 2017-06-28 |
| Needle, Hypodermic, Single Lumen | FMI | Class 2 | General Hospital | No | 2019-12-19 |
| Bit, Surgical | GFG | Class 1 | General, Plastic Surgery | No | 2013-12-24 |
| Catheter, Irrigation | GBX | Class 1 | General, Plastic Surgery | No | 2013-01-16 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2018-09-03 |
| Negative Pressure Wound Therapy Powered Suction Pump | OMP | Class 2 | General, Plastic Surgery | No | 2020-04-07 |
| Bur, Surgical, General & Plastic Surgery | GFF | Class 1 | General, Plastic Surgery | No | 2017-07-31 |
| Device, Specimen Collection | LIO | Class 1 | Microbiology | No | 2013-01-24 |
| System, Transport, Aerobic | JTW | Class 1 | Microbiology | No | 2013-01-24 |
| Plate, Bone | JEY | Class 2 | Dental | No | 2018-09-03 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | Class 1 | General, Plastic Surgery | No | 2014-04-28 |
| Dressing, Wound, Occlusive | NAD | Class 1 | General, Plastic Surgery | No | 2012-12-20 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2013-03-19 |
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2025-12-16 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | JDI | Class 2 | Orthopedic | No | 2013-02-26 |
| Drills, Burrs, Trephines & Accessories (Compound, Powered) | HBF | Class 2 | Neurology | No | 2013-02-18 |
| Applicator, Absorbent Tipped, Sterile | KXG | Class 1 | General Hospital | No | 2013-01-24 |
| Dressing, Wound, Hydrophilic | NAC | Class 1 | General, Plastic Surgery | No | 2012-12-20 |
| Pump, Air, Non-Manual, For Endoscope | FEQ | Class 2 | Gastroenterology, Urology | No | 2013-01-21 |
| Blade, Saw, Surgical, Cardiovascular | DWH | Class 1 | General, Plastic Surgery | No | 2013-12-24 |
| Chest Drainage Kit | PAD | Class 2 | General Hospital | No | 2025-07-25 |
| Blade, Saw, General & Plastic Surgery, Surgical | GFA | Class 1 | General, Plastic Surgery | No | 2014-07-09 |
Proprietary Names
Surgical_Inno3346 (BF) - YelloPort Elite Single Use Seal
DepuyOrtho (BF) - COVER, BURR HOLE
Surgical_Inno3346 (DV,BF*) - YelloPort Plus Single Use Valves
Surgical_Inno3346 (DV,BF*) - Logi Single Use Inserts
Surgical_Inno3346 (DV,BF*) - LogiFlex Gastric Band Positioning Device
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
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
Rocket8342 (BF) -R51400; R51400-00-PP; R51400-DP; R51401; R51401-00-PP; R51401-DP; R51411; R51411-00-PP
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)