FDA Registration
Active
🇬🇧 United Kingdom
Simpleware ScanIP Medical
Reg #: 3011676026
·
FEI: 3011676026
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- Simpleware Product Group, SYNOPSYS NORTHERN EUROPE
- Registration Number
- 3011676026
- FEI Number
- 3011676026
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Bradninch Hall, Castle Street
- City
- Exeter Devon
- Country
- GB
Regulatory Submissions
- 510(k) Number
- K142779
Owner / Operator
- Firm Name
- Synopsys Northern Europe
- Operator Number
- 10049175
- Address
- Bradninch Hall, Castle Street
- City
- Exeter
- State
- Devon
- Postal Code
- EX4 3PL
- Country
- GB
- Correspondent
- Jessica A James
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Image Processing, Radiological | LLZ | Class 2 | Radiology | No | 2015-04-24 |
Proprietary Names
Simpleware ScanIP Medical
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device