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Kortikalni zavrtanj
EUDAMEDClass IIb (EU MDR)
Ref NA.002.64Model Cortical screw 4.5x64mmRef NA.036.14Model Cortical screw 2x14mm
Identity
- Trade Name
- Kortikalni zavrtanj EUDAMEDKortikalni zavrtanj 2x14mm EUDAMED
- Device Name
- Cortical screw EUDAMED
- Model / Reference
- Cortical screw 4.5x64mm EUDAMEDNA.002.64 EUDAMEDCortical screw 2x14mm EUDAMEDNA.036.14 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08605029600907 EUDAMED08605029614720 EUDAMED
- Basic UDI-DI
- B-08605029600907 EUDAMEDB-08605029614720 EUDAMED
- EMDN Code
- P09120601 CORTICAL SCREWS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Croatia EUDAMEDHungary 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
Category: Orthopaedic bone screw (non-sliding)
Kortikalni zavrtanj by Narcissus doo — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Orthopaedic bone screw (non-sliding).
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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-08605029600907 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Narcissus doo
- EUDAMED SRN
- RS-MF-000022423
- Authorised Representative
- Narcmed Kft. HU-AR-000020491
Sources (2)
- EUDAMED 89097c2e-8ba1-408f-bd61-4b36efe130f8 61 fields · synced Jul 27, 2026
- EUDAMED 99143bd1-1230-4ad2-991c-599918f61878 61 fields · synced May 18, 2026