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AxoGuard Nerve Connector
EUDAMEDFDA 510(k)Class III (EU MDR)
Ref AGX215-2Ref AGX115-2Model AGX115-2Ref AGX310-2Ref AGX315-2
Identity
- Trade Name
- AxoGuard Nerve Connector EUDAMED
- Device Name
- AxoGuard Nerve Connector EUDAMED
- Model / Reference
- AGX215-2 EUDAMEDAGX115-2 EUDAMEDAGX310-2 EUDAMEDAGX315-2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-AGX215A4 EUDAMEDD-AGX1159X EUDAMEDD-AGX3109X EUDAMEDD-AGX315A9 EUDAMED
- Basic UDI-DI
- B-AGX215A4 EUDAMEDB-AGX1159X EUDAMEDB-AGX3109X EUDAMEDB-AGX315A9 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 — FDA_510K, MDD — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K162741 | Class III | Active |
| EUDAMED | European Union | CE/MDD | B-AGX215A4 | 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 (5)
- EUDAMED b28b56c0-91c6-4681-9283-985e55e8b186 61 fields · synced Jul 17, 2026
- EUDAMED 2ea5ca32-7337-41cb-8f2f-c3fdf1eb2c8b 61 fields · synced May 18, 2026
- EUDAMED 658a625f-dba4-4150-ad49-3f5fdee716ef 61 fields · synced May 19, 2026
- EUDAMED e99e5be5-bdbd-4372-b2fb-764ba6122621 61 fields · synced May 19, 2026
- FDA 510(k) K162741 1 fields · synced May 18, 2026