Trial Spacer-K
Ref SPK03
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number80314970617PD 08031497001852 | Date16 Sep 2026 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Spacer Trials
- Model / Reference
- SPK03
- Primary DI / UDI-DI
- 08031497001852
- Basic UDI-DI
- 80314970617PD
- Direct Marketing DI
- 08031497001852
- EMDN Code
- V06010102 Knee prostheses testing devices
- Device Class
- Class IIa
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- IT-MF-000027512
Other devices from Tecres S.p.A.
Properties
Other properties (12)
- Sterile: No
- Implantable: No
- 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
- Incorporates Medicinal Product: No