FDA Registration
Active
🇫🇮 Finland
Planmeca Fit
Reg #: 8030876
·
FEI: 1000207287
·
Expires 2025
Products
1
Proprietary Names
7
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- Planmeca Oy
- Registration Number
- 8030876
- FEI Number
- 1000207287
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Asentajankatu 6
- City
- Helsinki Uusimaa
- Country
- FI
Owner / Operator
- Firm Name
- Planmeca Oy
- Operator Number
- 10023612
- 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 |
|---|---|---|---|---|---|
| System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations | NOF | Class 2 | Dental | No | 2015-09-07 |
Proprietary Names
Planmeca Fit
PLANSCAN
Planmeca Romexis CAD/CAM
PlanCAD
Planmeca Emerald S
Planmeca Imprex
Planmeca Emerald
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device