Identity
- Trade Name
- ALAYA Spine Fiducial EUDAMED
- Device Name
- ALAYA Spine Fiducial EUDAMED
- Model / Reference
- SRAF-FID EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08437020847018 EUDAMED
- Basic UDI-DI
- 84370208470001FIEUKY EUDAMED
- EMDN Code
- V901699 SPECIALIST SURGICAL INSTRUMENTS AND KITS NOT INCLUDED IN OTHER CLASSES, SINGLE-USE - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
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: General internal orthopaedic fixation system implantation kit
ALAYA Spine Fiducial by Cyber Surgery S.L. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 84370208470001FIEUKY | Class I | Active |
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Manufacturer
- Manufacturer
- Cyber Surgery S.L.
- EUDAMED SRN
- ES-MF-000042958
Sources (2)
- EUDAMED 8d40ccef-8c11-4deb-b071-8da268f7b106 61 fields · synced Jun 18, 2026
- EUDAMED 2d9eec51-292e-4c6f-a388-5463c03bfbff 61 fields · synced Jun 18, 2026