Ortholox
by Ortolog Medi̇kal Sanayi̇ Ve Ti̇caret Anoni̇m Şi̇rketi̇ Türkiye EUDAMED
Ref 22-003-5500
EMDN P09120302
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberMDR.2292-2026/0029 | Date15 Jun 2026 | StatusActive |
| European Union | CE/MDD | NumberB-08682320051195 | Date8 Aug 2025 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR, CE/MDD Active
Certificates
- MDR.2292-2026/0029 Issued
Technical documentation EU MDR
- Notified body
- Notified body 2292
- Issued
- 15 Jun 2026
- Expires
- 14 Jun 2031
Specification
- Trade Name
- OrtholoxOrtholox® UHMWPE Sternal Cerclage Band System (Ti. Locking- w/Blunt Needle) - 5.0 x 500mm
- Device Name
- Ortholox UHMWPE Sternal Cerclage Band System (Ti. Locking- w/Blunt Needle) - 5.0 x 500mmUHMWPE Band System - Sterile
- Model / Reference
- 22-003-5500
- Primary DI / UDI-DI
- 08682320051195
- Basic UDI-DI
- B-08682320051195, 868232005SEBSH7
- EMDN Code
- P09120302 Cerclage devices, wires and binders
- Device Class
- Class IIb
- Market of Registration
- SpainTürkiye
Manufacturer details
- EUDAMED SRN
- TR-MF-000027137
Other devices from Ortolog Medi̇kal Sanayi̇ Ve Ti̇caret Anoni̇m Şi̇rketi̇
See all devices from Ortolog Medi̇kal Sanayi̇ Ve Ti̇caret Anoni̇m Şi̇rketi̇ →
Properties & raw data
Show properties, registry sources and raw records
Other properties (12)
- 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
Sources (2)
- EUDAMED 6f85a7b3-f8b9-4c47-8102-b02a0b85e602
- EUDAMED 08682320051195|868232005SEBSH7