FDA Registration
Active
🇬🇧 United Kingdom
Synergy Health Sterilisation UK Ltd
Reg #: 3002807310
·
FEI: 3002807310
·
Expires 2026
Products
109
Proprietary Names
86
Establishment Types
1
Classifications
109
Registration Details
- Registration Name
- Synergy Health Sterilisation UK Ltd
- Registration Number
- 3002807310
- FEI Number
- 3002807310
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Marcus Close
- City
- Berkshire Reading
- 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 |
|---|---|---|---|---|---|
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2013-03-25 |
| Bur, Dental | EJL | Class 1 | Dental | No | 2013-12-24 |
| Prosthesis, Hip, Femoral Component, Cemented, Metal | JDG | Class 2 | Orthopedic | No | 2016-01-18 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | JDI | Class 2 | Orthopedic | No | 2016-01-18 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2013-05-03 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2013-01-15 |
| Abutment, Implant, Dental, Endosseous | NHA | Class 2 | Dental | No | 2018-01-15 |
| Trephine, Manual, Ophthalmic | HRH | Class 1 | Ophthalmic | No | 2013-03-19 |
| Prosthesis, Hip, Hemi-, Femoral, Metal | KWL | Class 2 | Orthopedic | No | 2019-12-18 |
| Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | MEH | Class 2 | Orthopedic | No | 2019-12-18 |
| Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | KWY | Class 2 | Orthopedic | No | 2019-12-18 |
| Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | KNS | Class 2 | Gastroenterology, Urology | No | 2019-10-20 |
| Coagulator, Laparoscopic, Unipolar (And Accessories) | HFG | Class 2 | Obstetrics/Gynecology | No | 2013-05-03 |
| Hysteroscope (And Accessories) | HIH | Class 2 | Obstetrics/Gynecology | No | 2013-05-03 |
| Arthroscope | HRX | Class 2 | Orthopedic | No | 2013-01-10 |
| Resorbable Spinal Intervertebral Body Fixation Orthosis - Plate | OJB | Class 2 | Orthopedic | No | 2013-01-15 |
| Implant, Endosseous, Root-Form | DZE | Class 2 | Dental | No | 2014-05-11 |
| Kit, Surgical Instrument, Disposable | KDD | Class 1 | General, Plastic Surgery | No | 2013-03-19 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | KWS | Class 2 | Orthopedic | No | 2019-12-18 |
| Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | HSD | Class 2 | Orthopedic | No | 2019-12-18 |
| Shoulder Prosthesis, Reverse Configuration | PHX | Class 2 | Orthopedic | No | 2019-12-18 |
| Electrode, Electrosurgical, Active, Urological | FAS | Class 2 | Gastroenterology, Urology | No | 2019-10-20 |
| Washer, Bolt Nut | HTN | Class 2 | Orthopedic | No | 2013-03-11 |
| Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous | MBL | Class 2 | Orthopedic | No | 2019-04-01 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | Class 2 | Orthopedic | No | 2019-04-01 |
| Filler, Bone Void, Calcium Compound | MQV | Class 2 | Orthopedic | No | 2023-08-09 |
| Applicator, Absorbent Tipped, Sterile | KXG | Class 1 | General Hospital | No | 2013-01-24 |
| Pin, Fixation, Smooth | HTY | Class 2 | Orthopedic | No | 2013-01-15 |
| Dressing, Wound, Drug | FRO | Class U | Unknown | No | 2024-01-16 |
| Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented | OQH | Class 2 | Orthopedic | No | 2014-12-29 |
| Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented | OQG | 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 | KWZ | Class 2 | Orthopedic | No | 2014-12-29 |
| Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive | PBI | Class 2 | Orthopedic | No | 2014-12-29 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | LWJ | Class 2 | Orthopedic | No | 2013-03-25 |
| Lavage, Jet | FQH | Class 2 | General Hospital | No | 2023-08-17 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | Class 2 | Orthopedic | No | 2013-01-04 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive | OIY | Class 2 | Orthopedic | No | 2015-10-20 |
| Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment | HSZ | Class 1 | General, Plastic Surgery | No | 2024-08-06 |
| Motor, Drill, Pneumatic | HBB | Class 2 | Neurology | No | 2024-08-06 |
| Motor, Drill, Electric | HBC | Class 2 | Neurology | No | 2024-08-06 |
| Drills, Burrs, Trephines & Accessories (Simple, Powered) | HBE | Class 2 | Neurology | No | 2024-08-06 |
| Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | ERL | Class 2 | Ear, Nose, Throat | No | 2024-08-06 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing | NJL | Class 3 | Unknown | No | 2013-01-14 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2013-09-05 |
| Cystotome | HNY | Class 1 | Ophthalmic | No | 2013-03-19 |
| Airbrush | KOJ | Class 2 | Dental | No | 2026-03-16 |
| Hemostatic Wound Dressing Without Thrombin Or Other Biologics | QSY | Class U | Unknown | No | 2016-01-12 |
| Coagulator-Cutter, Endoscopic, Bipolar (And Accessories) | HIN | Class 2 | Obstetrics/Gynecology | No | 2019-10-20 |
| Mesh, Surgical, Polymeric | FTL | Class 2 | General, Plastic Surgery | No | 2013-11-15 |
| Dressing, Wound, Occlusive | NAD | Class 1 | General, Plastic Surgery | No | 2012-12-20 |
| Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | MBH | Class 2 | Orthopedic | No | 2023-11-20 |
| Bandage, Liquid | KMF | Class 1 | General Hospital | No | 2016-01-12 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2013-01-15 |
| Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer | KRO | Class 2 | Orthopedic | No | 2013-01-21 |
| Staple, Fixation, Bone | JDR | Class 2 | Orthopedic | No | 2013-01-15 |
| Fastener, Fixation, Biodegradable, Soft Tissue | MAI | Class 2 | Orthopedic | No | 2013-01-15 |
| Prosthesis, Finger, Constrained, Polymer | KYJ | Class 2 | Orthopedic | No | 2025-01-21 |
| Bone Grafting Material, Synthetic | LYC | Class 2 | Dental | No | 2013-02-05 |
| Resectoscope, Working Element | FDC | Class 2 | Gastroenterology, Urology | No | 2013-05-03 |
| Motor, Surgical Instrument, Ac-Powered | GEY | Class 1 | General, Plastic Surgery | No | 2016-11-18 |
| Protector, Skin Pressure | FMP | Class 1 | General Hospital | No | 2019-02-07 |
| Epilator, High Frequency, Needle-Type | KCW | Class 1 | General, Plastic Surgery | No | 2013-03-22 |
| Plate, Bone | JEY | Class 2 | Dental | No | 2013-01-15 |
| Barrier, Synthetic, Intraoral | NPK | Class 2 | Dental | No | 2013-01-15 |
| Pump, Air, Non-Manual, For Endoscope | FEQ | Class 2 | Gastroenterology, Urology | No | 2013-01-21 |
| Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component) | JDL | Class 3 | Orthopedic | No | 2013-01-03 |
| Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) | KWA | Class 3 | Orthopedic | No | 2013-01-03 |
| Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing | NRA | Class 3 | Unknown | No | 2013-01-03 |
| Accessories, Implant, Dental, Endosseous | NDP | Class 1 | Dental | No | 2015-09-18 |
| File, Pulp Canal, Endodontic | EKS | Class 1 | Dental | No | 2013-03-20 |
| Instrument, Diamond, Dental | DZP | Class 1 | Dental | No | 2017-12-20 |
| Coagulator-Cutter, Endoscopic, Unipolar (And Accessories) | KNF | Class 2 | Obstetrics/Gynecology | No | 2013-05-03 |
| Prosthesis, Elbow, Hemi-, Radial, Polymer | KWI | Class 2 | Orthopedic | No | 2015-08-12 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish | MAY | Class 2 | Orthopedic | No | 2013-01-03 |
| Lacrimal Stents And Intubation Sets | OKS | Class U | Unknown | No | 2013-01-10 |
| Dressing, Wound, Hydrophilic | NAC | Class 1 | General, Plastic Surgery | No | 2012-12-20 |
| Coagulator, Culdoscopic (And Accessories) | HFI | Class 2 | Obstetrics/Gynecology | No | 2019-10-20 |
| Agent, Polishing, Abrasive, Oral Cavity | EJR | Class 1 | Dental | No | 2026-03-16 |
| Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer | MBV | Class 2 | Orthopedic | No | 2013-01-03 |
| Needle, Dental | DZM | Class 1 | Dental | No | 2012-12-21 |
| Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method | DIC | Class 2 | Clinical Toxicology | No | 2013-05-03 |
| Forceps, Ophthalmic | HNR | Class 1 | Ophthalmic | No | 2013-03-19 |
| Specula, Ophthalmic | HNC | Class 1 | Ophthalmic | No | 2013-03-18 |
| Dressing, Wound, Hydrogel Without Drug And/Or Biologic | NAE | Class 1 | General, Plastic Surgery | No | 2013-03-27 |
| Fastener, Plate, Cranioplasty | HBW | Class 2 | Neurology | No | 2025-11-25 |
| Nursing Pad, Hydrogel | NTC | Class 1 | General Hospital | No | 2013-03-27 |
| Cannula, Ophthalmic, Posterior Capsular Polishing, Polyvinyl Acetal | MXY | Class 1 | Ophthalmic | No | 2013-03-19 |
| Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer | HRY | Class 2 | Orthopedic | No | 2013-03-25 |
| Scissors, Ophthalmic | HNF | Class 1 | Ophthalmic | No | 2013-03-18 |
| Gastroscope And Accessories, Flexible/Rigid | FDS | Class 2 | Gastroenterology, Urology | No | 2013-05-03 |
| Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer | KRR | Class 2 | Orthopedic | No | 2019-04-04 |
| Device, Fixation, Proximal Femoral, Implant | JDO | Class 2 | Orthopedic | No | 2015-08-12 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | KTT | Class 2 | Orthopedic | No | 2015-08-12 |
| Spatula, Ophthalmic | HND | Class 1 | Ophthalmic | No | 2013-03-18 |
| Curette, Ophthalmic | HNZ | Class 1 | Ophthalmic | No | 2013-03-19 |
| Strip, Polishing Agent | EHM | Class 1 | Dental | No | 2017-12-20 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2013-01-15 |
| Knife, Ophthalmic | HNN | Class 1 | Ophthalmic | No | 2013-03-18 |
| Allergen And Vaccine Delivery Needles | SCL | Class 2 | General Hospital | No | 2013-08-28 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2013-01-16 |
| Drill, Dental, Intraoral | DZA | Class 1 | Dental | No | 2016-11-12 |
| Clamp, Eyelid, Ophthalmic | HOD | Class 1 | Ophthalmic | No | 2013-09-13 |
| Needle, Ophthalmic Suturing | HNM | Class 1 | Ophthalmic | No | 2013-03-18 |
| Resectoscope | FJL | Class 2 | Gastroenterology, Urology | No | 2013-05-03 |
| Cannula, Ophthalmic | HMX | Class 1 | Ophthalmic | No | 2013-03-18 |
| Tape, Measuring, Rulers And Calipers | FTY | Class 1 | General, Plastic Surgery | No | 2014-12-11 |
| Hook, Ophthalmic | HNQ | Class 1 | Ophthalmic | No | 2013-03-19 |
| Probe, Lachrymal | HNL | Class 1 | Ophthalmic | No | 2013-03-18 |
Proprietary Names
DePuyIreland (RG,WP) - Corail
DePuyIreland (RG,WP) - Delta XTend
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
FirstWater14138 (RG) - 79933-03 - Cutimed Sorbact Hydroactive Border ST
FirstWater14138 (RG) - 79933-04 - Cutimed Sorbact Hydroactive Border ST
FirstWater14138 (RG) - 72646-05 - Cutimed Sorbact Hydroactive ST
FirstWater14138 (RG) - 79933-00 - Cutimed Sorbact
FirstWater14138 (RG) - 72646-03 - Cutimed Sorbact Hydroactive ST
FirstWater14138 (RG) - 72646-07 - Cutimed Sorbact Hydroactive ST
FirstWater14138 (RG) - 72646-04 - Cutimed Sorbact Hydroactive ST
FirstWater14138 (RG) - 72646-06 - Cutimed Sorbact Hydroactive ST
FirstWater14138 (RG) - 79933-02 - Cutimed Sorbact Hydroactive Border ST
DeSoutter8410 (DV,RG) - Lavage pump kits.
DeSoutter8410 (DV,RG) - Irriagtion Kits
Zimmer (DV,RG) - G7 Finned Acetabular Shell
Medivance9720 (RG) - Aquacut Quattro AquaCare Twin, AquaCare Single
Newclip11561 (MS) - BIT, DRILL
Zimmer Dental - Hex-Lock Short Abutment
DeSoutter8410 (DV) - Passing Pin
DeSoutter8410 (DV,RG) - Stericut
FirstWater14138 (RG) - F12LB/648/C1/2 Dr Scholl's Blister Cushion Dressing
FirstWater14138 (RG) - F10LB/599/G2/2 Dr Scholls Corn Cushion - New Liner
ZimmerDental9690 (RG) - Prepared Hex-Lock Abutment
Zimmer (DV,RG) - Taperloc Complete Microplasty Stem
FKG8620 (DK) - FKG
Zimmer (RG,DV) - Taperloc Complete, Size 5 And 6
DePuy (RG) - S-Rom Proximal Sleeves -Hip
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
Medivance9720 (RG) - BAG 45S5
Zimmer (DV,RG) - Taperloc Complete
Zimmer (DV,RG) - Vanguard SSK 360 Revision Knee System
ZimmerDental9690 (RG) - Zimmer Dental - SwissPlus Implant System
DePuyIreland (RG,WP) - Pinnacle
DORC10527 (VL1) - Forceps, Ophthalmic
BVI8325 (RG) - SPECULUM BLADED
FirstWater14138 (RG,SE) - Medela Breast Pads (USA)
FirstWater14138 (RG) - 73230-02 - Leukomed Control Sterile
FirstWater14138 (RG) - 73230-03 - Leukomed Control Sterile
FirstWater14138 (RG) - DUP86466-9 - Xtrasorb HCS Adhesive
FirstWater14138 (RG) - Russell Chest Seal
FirstWater14138 (RG) - DUP86322-9 Xtrasorb HCS
FirstWater14138 (RG) - 73230-05 - Leukomed Control Sterile
FirstWater14138 (RG) - CWL 1008 - KerraLite Cool Border
FirstWater14138 (RG) - CWL 1005 - KerraLite Cool
FirstWater14138 (RG) - Curad Soothe & Cool Dressing (56 x 26mm)
FirstWater14138 (RG) - CWL 1009 - KerraLite Cool Border
FirstWater14138 (RG) - 6030-4156 - Glaciergel
FirstWater14138 (RG) - CWL 1004 - KerraLite Cool
FirstWater14138 (RG) - 73230-00 - Leukomed Control Sterile
FirstWater14138 (RG) - CVS86433-9 Xtrasorb HCS Non- Adhesive 3""x3"" (cvs)
FirstWater14138 (RG) - 40-2979 - Hydrogel Dressing
FirstWater14138 (RG) - DUP86344 - Xtrasorb HCS 4.5" X 4.5"
FirstWater14138 (RG) - DUP86388-9 - Xtrasorb HCS Non- Adhesive
FirstWater14138 (RG) - 6030-4157 - Glaciergel
FirstWater14138 (RG) - 73230-01 - Leukomed Control Sterile
FirstWater14138 (RG) - Curad Soothe & Cool Dressing (74 x 45mm)
FirstWater14138 (RG) - CWL 1007 - KerraLite Cool Border
FirstWater14138 (RG) - CWL 1006 - KerraLite Cool
Zimmer (DV,RG,WP) - G7 OSSEOTI ACETUBLAR SHELLS
Zimmer (DV,RG) - G7 Freedom And Offset Liners, Freedom Head, Size 32
DORC10527 (VL1) - Scissors, Ophthalmic
BlinkMedical8355 (TH) - Surgical Forceps
ZimmerDental9690 (RG) - Zimmer Dental - Spline Twist Implant
BlinkMedical8355 (TH) - Surgical Manipulation Instruments
DORC10527 (VL1) - Spatula, Ophthalmic
Newclip11561 (MS) -Clavicle Plate screwdriver; Clavicle prehensor screwdriver countersink; Distal Radius Plate screwdriv
Newclip11561 (MS) - ACTIV Ankle RemovalkitACTIV Ankle screwdriver; Alians Fragment Specific screwdriver; Alians screwdri
Newclip11561 (MS) - Distal Radius removal kit; Elbow screwdriver; Foot & Hand Motion screwdriver; Footmotion screwdrive
Newclip11561 (MS) - HTO hexagonal screwdriver; Large screw screwdriver; Newclip Radius screwdriver; Newclip Shoulder
Alcon8548 (DK) - GRIESHABER ULTRASHARP Knife (Sclerotomy, Discission or Scleral Pocket)
Insulet5490 (SZ) - PodPals Adhesive Overlay
Bedal12006 (ED,VL2) - Bedal Flex XS, Bedal Flex S, Bedal Flex M
BVI8325 (RG) - LASIK CANNULA (DAYA)
D.O.R.C. (VL1) - Backflush instrument
DORC10527 (VL1) - Cannula, Ophthalmic
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)