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Onur Medi̇kal
EUDAMEDClass IIb (EU MDR)
Ref 714-OM-555Model SPINAL PEDICULAR SCREW
Identity
- Trade Name
- ONUR MEDİKAL EUDAMED
- Device Name
- POLYAXIAL PEDICLE SCREW, TITANIUM, D5, L55 FOR 6.0 MM ROD EUDAMED
- Model / Reference
- SPINAL PEDICULAR SCREW EUDAMED714-OM-555 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-8698682060119H9 EUDAMED
- Basic UDI-DI
- B-8698682060119H9 EUDAMED
- EMDN Code
- P09070302 THORACOLUMBOSACRAL FIXATION SYSTEMS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Onur Medi̇kal by Onur Medikal Sanayi ve Ticaret Anonim Şirketi — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-8698682060119H9 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Onur Medikal Sanayi ve Ticaret Anonim Şirketi
- EUDAMED SRN
- TR-MF-000016533
Sources (1)
- EUDAMED 9014b133-a185-468c-a664-c5ca5bac8639 61 fields · synced Oct 6, 2026