FDA Registration
Active
🇫🇮 Finland
Planmed Clarity 2D, Planmed Clarity S
Reg #: 8043728
·
FEI: 3002807903
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Planmed Oy
- Registration Number
- 8043728
- FEI Number
- 3002807903
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Sorvaajankatu 7
- City
- Helsinki Uusimaa
- Country
- FI
Regulatory Submissions
- 510(k) Number
- K211720
Owner / Operator
- Firm Name
- Planmed Oy
- Operator Number
- 10023610
- Address
- Asentajankatu 6
- City
- Helsinki
- State
- Uusimaa
- Postal Code
- 00880
- Country
- FI
- Correspondent
- Niina M Vuorikallas
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Full Field Digital, System, X-Ray, Mammographic | MUE | Class 2 | Radiology | No | 2022-08-16 |
Proprietary Names
Planmed Clarity 2D, Planmed Clarity S
Establishment Types
Manufacture Medical Device