Extramedullary Jig Carbon
by Orthokey Italia SRL United States EUDAMED
Ref 20902403Model ORTHOKEY Surgical instruments IR
EMDN L0999
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number805267596SurgicalInstrD9 | Date24 Mar 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Certificates
- IT348354 Issued
Quality management system EU MDR
- Notified body
- BUREAU VERITAS ITALIA S.P.A. 1370
- Issued
- 17 Dec 2025
- Expires
- 16 Dec 2030
Specification
- Model / Reference
- ORTHOKEY Surgical instruments IR, 20902403
- Primary DI / UDI-DI
- 08052675960211
- Basic UDI-DI
- 805267596SurgicalInstrD9
- Direct Marketing DI
- 08052675960211
- EMDN Code
- L0999 Orthopaedic and traumatological surgery instruments, reusable - other
- Device Class
- Class I
- Market of Registration
- Italy
Manufacturer details
- EUDAMED SRN
- IT-MF-000026488
Properties & raw data
Show properties, registry sources and raw records
Other properties (12)
- Sterile: No
- Implantable: 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
Sources (1)
- EUDAMED fbc9d587-844a-4bf0-ba8d-5745845ed5ae