Identity
- Trade Name
- Axonics PNE Lead EUDAMEDAxonics FDA UDI
- Generic Name
- Implantable electrical stimulation system intraoperative test lead FDA UDI
- Device Name
- Axonics PNE Lead EUDAMEDPNE Lead FDA UDI
- Model / Reference
- 1901 EUDAMEDFDA UDI
- Description
- PNE Lead FDA UDI
Identifiers
- Catalog Number
- 1901 FDA UDI
- Primary DI / UDI-DI
- 10810005340127 EUDAMEDFDA UDI
- Basic UDI-DI
- B-10810005340127 EUDAMED
- FDA Product Code
- QON FDA UDIEZW FDA UDI
- EMDN Code
- J020403 SACRAL SPINE NEUROSTIMULATION LEADS EUDAMED
- GMDN Term
- Implantable electrical stimulation system intraoperative test lead FDA UDI
Classification
- Device Class
- Class AIMDD EUDAMEDClass III FDA UDI
- Regulation Number
- 876.5270 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Axonics PNE Lead by Axonics Inc. — Class AIMDD — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-10810005340127 | Class AIMDD | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class AIMDD | Pending data |
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Manufacturer
- Manufacturer
- Axonics Inc.
- EUDAMED SRN
- US-MF-000008413
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 41ab3e1f-2311-4801-9a68-6bdc328592bd 61 fields · synced Jun 18, 2026
- FDA UDI 44502158-ec98-4d12-b6da-f0856a4cfac3 35 fields · synced May 30, 2026