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Kalkaneus ploča 70mm
EUDAMEDClass IIb (EU MDR)
Ref NA.KL.3570.LModel Calcaneal plate 70mm
Identity
- Trade Name
- Kalkaneus ploča 70mm EUDAMED
- Device Name
- Calcaneal plate EUDAMED
- Model / Reference
- Calcaneal plate 70mm EUDAMEDNA.KL.3570.L EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08605029613860 EUDAMED
- Basic UDI-DI
- B-08605029613860 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
Kalkaneus ploča 70mm by Narcissus doo — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
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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-08605029613860 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Narcissus doo
- EUDAMED SRN
- RS-MF-000022423
- Authorised Representative
- Narcmed Kft. HU-AR-000020491
Sources (1)
- EUDAMED 2b91dcb2-e057-4d8f-86a8-5aa868af3f84 61 fields · synced Aug 2, 2026