FDA Registration
Active
🇬🇧 United Kingdom
Avantgarde +T
Reg #: 3005533818
·
FEI: 3005533818
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- PROSYS INTERNATIONAL LTD
- Registration Number
- 3005533818
- FEI Number
- 3005533818
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Suite 4, 2 Allington Close; Wimbledon; England
- City
- London London, City of
- Country
- GB
Regulatory Submissions
- 510(k) Number
- K193325
Owner / Operator
- Firm Name
- Prosys International Ltd
- Operator Number
- 10048819
- Address
- Suite 4, 2 Allington Close
- City
- Wimbledon
- State
- England
- Postal Code
- SW19 2AP
- Country
- GB
US Agent
- Business Name
- Registrar Corp
- Contact Name
- David Lennarz
- Address
- 144 Research Drive
- City
- Hampton
- State
- VA
- ZIP
- 23666
- Country
- US
- [email protected]
- Phone
- 757 2240177
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Tubes, Gastrointestinal (And Accessories) | KNT | Class 2 | Gastroenterology, Urology | No | 2021-07-02 |
Proprietary Names
Avantgarde +T
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Develop Specifications But Do Not Manufacture At This Facility