PH14-0146
Ref PH14-0146Model Primary implant uncemented metal acetabular cups
Active
CE MDR
Valid until
31 Aug 2030
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number3700535100020PK 03700535111246 | Date27 May 2026 | StatusActive |
Certificates
- MDR 785393 Active
Technical documentation EU MDR
- Certifier
- BSI Group The Netherlands B.V. 2797
- Issued
- 1 Sep 2025
- Expires
- 31 Aug 2030
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Model / Reference
- Primary implant uncemented metal acetabular cups, PH14-0146
- Primary DI / UDI-DI
- 03700535111246
- Basic UDI-DI
- 3700535100020PK
- EMDN Code
- P090803010201 Primary implant uncemented metal acetabular cups
- Device Class
- Class III
- EU market of registration
- France
Manufacturer details
- EUDAMED SRN
- CH-MF-000018319
- Authorised representative
- X.NOV FR-AR-000007682
Other devices from X.nov Medical Technology
Properties
Other properties (11)
- 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