ProphyStar G2 - weiss, mittel
Ref PSM2Model 16412
ProphyStar G2 - weiss, mittel (PSM2) is a Class IIa device made by Edenta Etablissement, registered in EUDAMED on 2 Feb 2022 (Basic UDI-DI ++E31216412DU) with CE/MDR certificate 1000183128 valid until 26 Mar 2030, active as of 25 Oct 2026.
Active
CE MDR
Valid until
26 Mar 2030
FDA recalls
Not applicable
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number1000183128 | Date27 Mar 2025 | StatusActive |
Official records
- EUDAMED public site ++E31216412DU
Certificates
- 1000183128 Active
Quality management system EU MDR
- Certifier
- DQS Medizinprodukte GmbH 0297
- Issued
- 27 Mar 2025
- Expires
- 26 Mar 2030
Timeline
- Registered EUDAMED ++E31216412DU
- Certificate issued EUDAMED 1000183128
- Certificate expires EUDAMED 1000183128
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device name
- Polierer / Arkansas
- Model / reference
- 16412, PSM2
- Primary DI / UDI-DI
- E312PSM21
- Basic UDI-DI
- ++E31216412DU
- Unit of use DI
- E312PSM2101
- EMDN code
- Q01010403 Dental abrasive and polishing materials
- Device class
- Class IIa
- EU registration type
- Standard device
- EU market of registration
- Liechtenstein
Manufacturer details
- EUDAMED SRN
- LI-MF-000011937
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