Union Dental SA IdoAcetal
Ref T12 xx-T25xxModel TSM Acetal Dental
Active
CE MDR
Valid until
7 May 2028
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number8052275590009TSMAcetDenGH 08055162506176 | Date22 Sep 2026 | StatusActive |
Certificates
- 0425-MDR-030025-02 Active
Quality management system EU MDR
- Certifier
- ICIM S.P.A. 0425
- Issued
- 30 Jul 2026
- Expires
- 7 May 2028
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- TSM Acetal Dental
- Model / Reference
- TSM Acetal Dental, T12 xx-T25xx
- Primary DI / UDI-DI
- 08055162506176
- Basic UDI-DI
- 8052275590009TSMAcetDenGH
- Direct Marketing DI
- 08055162506176
- EMDN Code
- Q010699 Materials for the preparation of custom-made dental devices - other
- Device Class
- Class IIa
- EU market of registration
- Spain
Manufacturer details
- EUDAMED SRN
- SM-MF-000057480
- Authorised representative
- Monticelli Giovanni Alessandro IT-AR-000055000
Other devices from Pressing Dental Srl
Properties
Other properties (13)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No