Reconstruction nail - Reconstruction nail
by MEDIN, a.s.
Ref 397129790561Model Nail
Active
CE MDR
Valid until
31 Aug 2028
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number85917126010101V4 08591712399633 | Date7 Aug 2025 | StatusActive |
Certificates
- 2023-MDR/QS-028 Active
Quality management system EU MDR
- Certifier
- 3EC International a.s. 2265
- Issued
- 31 Aug 2023
- Expires
- 31 Aug 2028
- 2023-MDR/QS-028/A Active
Quality management system EU MDR
- Certifier
- 3EC International a.s. 2265
- Issued
- 27 Jan 2025
- Expires
- 31 Aug 2028
- 2023-MDR/TD-028/A Active
Technical documentation EU MDR
- Certifier
- 3EC International a.s. 2265
- Issued
- 27 Jan 2025
- Expires
- 31 Aug 2028
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Reconstruction nail
- Model / Reference
- Nail, 397129790561
- Primary DI / UDI-DI
- 08591712399633
- Basic UDI-DI
- 85917126010101V4
- Direct Marketing DI
- 08591712399633
- EMDN Code
- P09120201 Intramedullary nails
- Models / Variants
- Reconstruction nail
- Device Class
- Class IIb
- EU market of registration
- Czechia
Manufacturer details
- EUDAMED SRN
- CZ-MF-000012371
Other devices from MEDIN, a.s.
Properties
Other properties (13)
- Sterile: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- Sutures: 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