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Neurosign V4 IntraOperative Nerve Monitor
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref 4230-00
Identity
- Trade Name
- Neurosign V4 IntraOperative Nerve Monitor EUDAMEDFDA UDI
- Generic Name
- Nerve-locating system FDA UDI
- Device Name
- Neurosign V4 IntraOperative Nerve Monitor EUDAMED
- Model / Reference
- 4230-00 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 05060229531858 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05060229531858 EUDAMED
- 510(k) Number
- K181559 FDA UDI
- FDA Product Code
- PDQ FDA UDIETN FDA UDI
- EMDN Code
- Z121002 NERVOUS SYSTEM MONITORING SYSTEMS EUDAMED
- GMDN Term
- Nerve-locating system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 874.1820 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Neurosign V4 IntraOperative Nerve Monitor by The Magstim Company Limited — Class IIa — FDA_510K, MDD — listed in EUDAMED, FDA GUDID, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K181559 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K203684 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-05060229531858 | Class IIa | Active |
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Manufacturer
- Manufacturer
- The Magstim Company Limited
- EUDAMED SRN
- GB-MF-000003956
- Authorised Representative
- Technomed Europe NL-AR-000002048
Sources (3)
- EUDAMED c7bd1891-4037-40ff-b5b8-5cbda8775e53 61 fields · synced Oct 6, 2026
- FDA UDI 1cdc83d0-45b0-447b-a898-b4e4c2f8eea4 35 fields · synced May 29, 2026
- FDA 510(k) K181559 1 fields · synced May 18, 2026