Spacer-G 54 Xl
Ref SPC54/GXL
Active
CE MDR
Valid until
16 Jan 2028
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number80314970211ND 28031497000279 | Date26 Jun 2026 | StatusActive |
Certificates
- MDR 738108 Active
Technical documentation EU MDR
- Certifier
- BSI Group The Netherlands B.V. 2797
- Issued
- 10 Dec 2025
- Expires
- 16 Jan 2028
- Reason
- Other
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
- Austria
- Belgium
- Bulgaria
- Croatia
- Cyprus
- Czechia
- Denmark
- Estonia
- Finland
- France
- Germany
- Greece
- Hungary
- Iceland
- Ireland
- Italy
- Latvia
- Lithuania
- Luxembourg
- Malta
- Netherlands
- Northern Ireland
- Norway
- Poland
- Portugal
- Romania
- Slovakia
- Slovenia
- Spain
- Sweden
- Türkiye
Specification
- Device Name
- Spacer-G
- Model / Reference
- SPC54/GXL
- Primary DI / UDI-DI
- 28031497000279
- Basic UDI-DI
- 80314970211ND
- EMDN Code
- P090805 Hip prostheses spacers
- Device Class
- Class III
- EU market of registration
- Italy
Manufacturer details
- EUDAMED SRN
- IT-MF-000027512
Other devices from Tecres S.p.A.
Properties
Other properties (9)
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No