Identity
- Trade Name
- AxoGuard Nerve Connector EUDAMED
- Device Name
- AxoGuard Nerve Connector EUDAMED
- Model / Reference
- AGX415-2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-AGX415AE EUDAMED
- Basic UDI-DI
- B-AGX415AE EUDAMED
- EMDN Code
- P900402 RESORBABLE FILLING AND RECONSTRUCTION DEVICES EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Denmark EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
AxoGuard Nerve Connector by Cook Biotech Incorporated — Class III — 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-AGX415AE | Class III | Active |
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Manufacturer
- Manufacturer
- Cook Biotech Incorporated
- EUDAMED SRN
- US-MF-000001990
- Authorised Representative
- Cook Biotech Europe ApS DK-AR-000000965
Sources (1)
- EUDAMED 76201474-9946-46a3-a6db-a4f75578b1f6 61 fields · synced Jun 17, 2026