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Axonics Accessory Tunneling Tool
EUDAMEDClass AIMDD (EU MDR)
Ref 9010
by Axonics Inc.
Identity
- Trade Name
- Axonics Accessory Tunneling Tool EUDAMED
- Device Name
- Axonics Accessory Tunneling Tool EUDAMED
- Model / Reference
- 9010 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10810005340462 EUDAMED
- Basic UDI-DI
- B-10810005340462 EUDAMED
- EMDN Code
- J020480 SACRAL SPINE IMPLANTABLE NEUROSTIMULATORS - ACCESSORIES EUDAMED
Classification
- Device Class
- Class AIMDD EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
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
Axonics Accessory Tunneling Tool by Axonics Inc. — Class AIMDD — MDD, AIMDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/AIMDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-10810005340462 | Class AIMDD | Active |
| EUDAMED | European Union | CE/AIMDD | B-10810005340462 | Class AIMDD | Active |
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Manufacturer
- Manufacturer
- Axonics Inc.
- EUDAMED SRN
- US-MF-000008413
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED 0b8ea059-817e-4cff-8353-fba54ad27359 61 fields · synced Aug 4, 2026