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Axonics Accessory Tunneling Tool and Directional Guide
EUDAMEDClass AIMDD (EU MDR)
Ref 9012
by Axonics Inc.
Identity
- Trade Name
- Axonics Accessory Tunneling Tool and Directional Guide EUDAMED
- Device Name
- Axonics Accessory Tunneling Tool and Directional Guide EUDAMED
- Model / Reference
- 9012 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10810005340318 EUDAMED
- Basic UDI-DI
- B-10810005340318 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 and Directional Guide by Axonics Inc. — Class AIMDD — 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-10810005340318 | 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 6a7a0b06-9fcc-4af3-8713-3643949d448d 61 fields · synced Jun 19, 2026