Identity
- Trade Name
- A2L® INSTRUMENT EUDAMED
- Device Name
- A2L surgical instrument, non-sterile EUDAMED
- Model / Reference
- AIR6 EUDAMED
Identifiers
- Primary DI / UDI-DI
- M614AIR61 EUDAMED
- Basic UDI-DI
- B-M614AIR61 EUDAMED
- EMDN Code
- L1199 NEUROSURGERY INSTRUMENTS, REUSABLE - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
A2l® Instrument by Eurospine Sarl — Class I — MDD — listed in EUDAMED — regulatory data on deviCERTS
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-M614AIR61 | Class I | Active |
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Manufacturer
- Manufacturer
- Eurospine Sarl
- EUDAMED SRN
- FR-MF-000001820
Sources (1)
- EUDAMED d4c09004-c469-4a5c-9f0e-fc35fb3b48b2 61 fields · synced Jun 19, 2026