FDA Registration
Active
🇬🇧 United Kingdom
GE Ultrasound Transducers
Reg #: 3011763071
·
FEI: 3011763071
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- PILSON DIRECT TRADING LIMITED
- Registration Number
- 3011763071
- FEI Number
- 3011763071
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 25 Thames Street, Gateshead
- City
- Newcastle Newcastle upon Tyne
- Country
- GB
Regulatory Submissions
- 510(k) Number
- K141093
Owner / Operator
- Firm Name
- Pilson Direct Trading Limited
- Operator Number
- 10049953
- Address
- 25 Thames Street, Gateshead
- City
- Newcastle
- State
- Newcastle upon Tyne
- Postal Code
- NE8 3SP
- Country
- GB
- Correspondent
- Elvira Pili
US Agent
- Business Name
- The Wood Burditt Group
- Contact Name
- Richard Chun
- Address
- 10 E. Scranton Avenue, Suite 201, Lake Bluff, Lake Bluff,
- City
- Lake Bluff
- State
- IL
- ZIP
- 60044
- Country
- US
- [email protected]
- Phone
- 847 2347500 ext. 204
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Transducer, Ultrasonic, Diagnostic | ITX | Class 2 | Radiology | No | 2023-01-31 |
Proprietary Names
GE Ultrasound Transducers
Establishment Types
Export Device to the United States But Perform No Other Operation on Device