Identity
- Trade Name
- ALAYA Spine A-B Tool Guide EUDAMED
- Device Name
- ALAYA Spine Surgical Instruments EUDAMED
- Model / Reference
- SRAI-ABTG EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08437020847094 EUDAMED
- Basic UDI-DI
- 84370208470001IREUN2 EUDAMED
- Direct Marketing DI
- 08437020847094 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 A-B Tool Guide 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 |
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Manufacturer
- Manufacturer
- Cyber Surgery S.L.
- EUDAMED SRN
- ES-MF-000042958
Sources (1)
- EUDAMED 7f45c2cd-0657-403d-8e2f-605cfb6e8a68 61 fields · synced Jul 14, 2026