Identity
- Trade Name
- Neurosign 100 Unit EUDAMEDNeurosign 100 FDA UDI
- Generic Name
- Nerve-locating system, line-powered FDA UDI
- Device Name
- Neurosign 100 Unit EUDAMEDIntraoperative nerve monitor FDA UDI
- Model / Reference
- 9883-01 EUDAMEDFDA UDI
- Description
- Intraoperative nerve monitor FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05060229530943 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05060229530943 EUDAMED
- 510(k) Number
- K923056 FDA UDI
- FDA Product Code
- ETN FDA UDI
- EMDN Code
- Z121002 NERVOUS SYSTEM MONITORING SYSTEMS EUDAMED
- GMDN Term
- Nerve-locating system, line-powered FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 874.1820 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- 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
Yes
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 100 Unit by The Magstim Company Limited — Class IIa — 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-05060229530943 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- The Magstim Company Limited
- EUDAMED SRN
- GB-MF-000003956
- Authorised Representative
- Technomed Europe NL-AR-000002048
Sources (2)
- EUDAMED 0882f15b-d4ef-46f2-95f5-8d5889ad916c 61 fields · synced Oct 6, 2026
- FDA UDI 279a4a9d-660e-480b-ae55-e6c896048fbf 35 fields · synced May 30, 2026