← Back to catalogue
Axonics Tined Lead (with Percutaneous Extension)
EUDAMEDFDA UDIClass AIMDD (EU MDR)
Ref 2201
by Axonics Inc.
Identity
- Trade Name
- Axonics Tined Lead (with Percutaneous Extension) EUDAMEDAxonics FDA UDI
- Generic Name
- Sacral plexus implantable incontinence-control electrical stimulation system electrode FDA UDI
- Device Name
- Axonics Tined Lead (with Percutaneous Extension) EUDAMEDTined Lead FDA UDI
- Model / Reference
- 2201 EUDAMEDFDA UDI
- Description
- Tined Lead FDA UDI
Identifiers
- Catalog Number
- 2201 FDA UDI
- Primary DI / UDI-DI
- 10810005340158 EUDAMEDFDA UDI
- Basic UDI-DI
- B-10810005340158 EUDAMED
- FDA Product Code
- QON FDA UDIEZW FDA UDI
- EMDN Code
- J020403 SACRAL SPINE NEUROSTIMULATION LEADS EUDAMED
- GMDN Term
- Sacral plexus implantable incontinence-control electrical stimulation system electrode 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
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Conditional FDA UDI
Axonics Tined Lead (with Percutaneous Extension) 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-10810005340158 | Class AIMDD | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class AIMDD | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Axonics Inc.
- EUDAMED SRN
- US-MF-000008413
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 2858cb20-1920-4cb5-8fd5-1edfa88afe8c 61 fields · synced Jun 18, 2026
- FDA UDI fbb87879-93b7-4ea3-a32b-95cff4524e58 35 fields · synced May 30, 2026