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Skyline Anterior Cervical Plate System
EUDAMEDClass IIb (EU MDR)
Ref 186850017SModel SKYLINE Anterior Cervical Plate System Screws
Identity
- Trade Name
- SKYLINE ANTERIOR CERVICAL PLATE SYSTEM EUDAMED
- Device Name
- Screws EUDAMED
- Model / Reference
- SKYLINE Anterior Cervical Plate System Screws EUDAMED186850017S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10705034412405 EUDAMED
- Basic UDI-DI
- 0705034a002225Q EUDAMED
- EMDN Code
- P09070301 CERVICAL FIXATION SYSTEMS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Sutures
Yes
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Cervical spine immobilization system, single-use
Skyline Anterior Cervical Plate System by Medos International Sarl — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Cervical spine immobilization system, single-use.
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0705034a002225Q | Class IIb | Active |
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Manufacturer
- Manufacturer
- Medos International SARL
- EUDAMED SRN
- CH-MF-000014268
- Authorised Representative
- DePuy Ireland UC IE-AR-000009328
Sources (1)
- EUDAMED 6f8bc4b3-dc75-46f6-94af-942ae31714b8 61 fields · synced May 23, 2026