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Anatomska ploča za dist.med.tib. 9 otvora L
EUDAMEDClass IIb (EU MDR)
Ref APDT9LModel Anatomical plate for dist.med.tib.9 holes LRef APDT9DModel Anatomical plate for dist.med.tib. 9 holes R
Identity
- Trade Name
- Anatomska ploča za dist.med.tib. 9 otvora L EUDAMEDAnatomska ploča za dist.med.tib. 9 otvora EUDAMED
- Device Name
- Anatomical plate for dist.med.tib. EUDAMED
- Model / Reference
- Anatomical plate for dist.med.tib.9 holes L EUDAMEDAPDT9L EUDAMEDAnatomical plate for dist.med.tib. 9 holes R EUDAMEDAPDT9D EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08605029608972 EUDAMED08605029608965 EUDAMED
- Basic UDI-DI
- B-08605029608972 EUDAMEDB-08605029608965 EUDAMED
- EMDN Code
- P09120599 BONE FIXATION PLATES - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Hungary 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 fixation plate, non-bioabsorbable
Anatomska ploča za dist.med.tib. 9 otvora L by Narcissus doo — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic fixation plate, non-bioabsorbable.
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- osteo-WEDGE2 12 Degree Angulated Bone Plate Implant, Large — Gramedica · Class II
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-08605029608972 | 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 638faa6a-0c5f-4723-a7af-0bf038376e8e 61 fields · synced Jul 20, 2026
- EUDAMED 4f1e9459-033e-4fb1-84b4-0f1478080311 61 fields · synced May 18, 2026