Planmeca Pro50 S
by Planmeca Oy
Ref 30064300
Planmeca Pro50 S (30064300) is a Class IIa device made by Planmeca Oy, registered in EUDAMED on 17 Mar 2025 (Basic UDI-DI 6430035420225M) with CE/MDR certificate FI23/00000059 valid until 26 Jun 2030, active as of 7 Nov 2026.
Active
CE MDR
Valid until
26 Jun 2030
FDA recalls
Not applicable
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberFI23/00000059 | Date17 Sep 2025 | StatusActive |
Official records
- EUDAMED public site 6430035420225M
Certificates
- FI23/00000059 Active
Quality management system EU MDR
- Certifier
- SGS FIMKO OY 0598
- Issued
- 17 Sep 2025
- Expires
- 26 Jun 2030
- Reason
- Other
Timeline
- Registered EUDAMED 6430035420225M
- Certificate issued EUDAMED FI23/00000059
- Certificate expires EUDAMED FI23/00000059
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device name
- Planmeca Pro50
- Model / reference
- 30064300
- Primary DI / UDI-DI
- 06430035421091
- Basic UDI-DI
- 6430035420225M
- Direct marketing DI
- 06430035421091
- EMDN code
- Z12110101 Dental treatment units
- Device class
- Class IIa
- EU registration type
- Standard device
- EU market of registration
- France
Manufacturer details
- EUDAMED SRN
- FI-MF-000006499
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