VARIANT, Hlavice CoCrMo (∢12/14) 28 S
Ref O01210-2800-12018
Active
CE MDR
Valid until
26 Apr 2029
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number2026-MDR/QS-003/A | Date17 Sep 2026 | StatusActive |
Certificates
- 2026-MDR/QS-003/A Active
Quality management system EU MDR
- Certifier
- 3EC International a.s. 2265
- Issued
- 17 Sep 2026
- Expires
- 26 Apr 2029
- Reason
- Change approved
- 2026-MDR/TD-003/A Active
Technical documentation EU MDR
- Certifier
- 3EC International a.s. 2265
- Issued
- 17 Sep 2026
- Expires
- 26 Apr 2029
- Reason
- Change approved
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- VARIANT, Modular lower extremity replacement
- Model / Reference
- O01210-2800-12018
- Primary DI / UDI-DI
- 08595565120321
- Basic UDI-DI
- 8592395VARIANTLE64
- Direct Marketing DI
- 08595565120321
- EMDN Code
- P090804050202 Metal femoral heads, total hip replacement
- Device Class
- Class III
- EU market of registration
- Czechia
Manufacturer details
- EUDAMED SRN
- CZ-MF-000019992
Other devices from ProSpon, spol. s r.o.
Properties
Other properties (10)
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No