BASE LINK ANTIROTAZIONALE sTS HT 2
Ref 2405331
Active
CE MDR
Valid until
26 Sep 2028
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number805214171200B019R 08056284293296 | Date14 Sep 2026 | StatusActive |
Certificates
- 0425-MDR-030042-04 Active
Quality management system EU MDR
- Certifier
- ICIM S.P.A. 0425
- Issued
- 20 Jun 2025
- Expires
- 26 Sep 2028
- 0425-MDR-030042-04 Active
Quality management system EU MDR
- Certifier
- ICIM S.P.A. 0425
- Issued
- 20 Jun 2026
- Expires
- 26 Sep 2028
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Componenti Protesiche / Prosthetic Components
- Model / Reference
- 2405331
- Primary DI / UDI-DI
- 08056284293296
- Basic UDI-DI
- 805214171200B019R
- EMDN Code
- P010299 Odontological prostheses - other
- Device Class
- Class IIb
- EU market of registration
- Italy
Manufacturer details
- EUDAMED SRN
- IT-MF-000022007
Other devices from Prodent Italia S.r.l.
Properties
Other properties (12)
- Sterile: 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