Identity
- Trade Name
- VNS Therapy® EUDAMEDVNS Therapy® Demipulse Duo® Model 104 Generator FDA UDI
- Generic Name
- Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system FDA UDI
- Device Name
- VNS Therapy® Demipulse Duo® Generator EUDAMEDImplantable Pulse Generator FDA UDI
- Model / Reference
- Model 104 EUDAMED104 EUDAMEDFDA UDI
- Description
- Implantable Pulse Generator FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05425025750047 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05425025750047 EUDAMED
- PMA Number
- P970003 FDA UDI
- FDA Product Code
- MUZ FDA UDILYJ FDA UDI
- EMDN Code
- J020301,J020399 EUDAMED
- GMDN Term
- Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system FDA UDI
Classification
- Device Class
- Class AIMDD EUDAMEDClass III FDA UDI
- Market of Registration
- Italy 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Conditional FDA UDI
VNS Therapy® by LivaNova USA, 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-05425025750047 | Class AIMDD | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class AIMDD | Pending data |
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Manufacturer
- Manufacturer
- LivaNova USA, Inc.
- EUDAMED SRN
- US-MF-000038770
- Authorised Representative
- LivaNova Belgium NV BE-AR-000014035
Sources (2)
- EUDAMED 0ca2f469-8f61-4b80-9a26-a532eb6f4b0e 61 fields · synced Jun 8, 2026
- FDA UDI ab384757-b3f9-4f51-80a1-00813af8f75a 36 fields · synced May 25, 2026