FDA Registration
Active
🇬🇧 United Kingdom
CREO MEDICAL LTD
Reg #: 3014925413
·
FEI: 3014925413
·
Expires 2026
Products
3
Proprietary Names
9
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- CREO MEDICAL LTD
- Registration Number
- 3014925413
- FEI Number
- 3014925413
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Unit 2, Beaufort Park, Beaufort Park Road
- City
- CHEPSTOW Monmouthshire
- Country
- GB
Regulatory Submissions
- 510(k) Number
- K242983
Owner / Operator
- Firm Name
- Creo Medical Ltd
- Operator Number
- 10058797
- Address
- Creo House, Unit 2 Beaufort Park, Beaufort Park Way
- City
- CHEPSTOW
- State
- Monmouthshire
- Postal Code
- NP16 5UH
- Country
- GB
- Correspondent
- Steven J Patterson
US Agent
- Business Name
- Creo Medical Inc.
- Contact Name
- Richard Weir
- Address
- 100 Reserve Road Suite B400
- City
- Danbury
- State
- CT
- ZIP
- 06810
- Country
- US
- [email protected]
- Phone
- 203 9171770
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | KNS | Class 2 | Gastroenterology, Urology | No | 2025-02-06 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2025-02-06 |
| System, Ablation, Microwave And Accessories | NEY | Class 2 | General, Plastic Surgery | No | 2025-02-06 |
Proprietary Names
CROMA Electrosurgical Generator
Creo Electrosurgical System with NP1 Instrument
SpydrBlade Flex
Speedboat
CROMA Electrosurgical System
Footswitch (7-PG1-132)
Reusable Interface Cable 1.5 m (PRD-IFC-002)
Speedboat® UltraSlim
Speedboat Notch
Establishment Types
Manufacture Medical Device