Identity
- Trade Name
- ALAYA Spine Surgical Cover Tool EUDAMED
- Device Name
- ALAYA Spine Surgical Instruments EUDAMED
- Model / Reference
- SRAI-SCT EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08437020847087 EUDAMED
- Basic UDI-DI
- 84370208470001IREUN2 EUDAMED
- Direct Marketing DI
- 08437020847087 EUDAMED
- EMDN Code
- L0919 ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENT KITS, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
ALAYA Spine Surgical Cover Tool by Cyber Surgery S.L. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 84370208470001IREUN2 | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Cyber Surgery S.L.
- EUDAMED SRN
- ES-MF-000042958
Sources (1)
- EUDAMED 05e797a7-9636-42fd-a0cf-e00c477e2b8b 61 fields · synced Jun 18, 2026