Identity
- Trade Name
- NeMus 2 EUDAMEDNeMus 2 600 FDA UDI
- Generic Name
- Evoked-potential graphic recording system FDA UDI
- Device Name
- EMG Family EUDAMEDEEG/EMG/EP System FDA UDI
- Model / Reference
- B9800066601 EUDAMEDFDA UDI
- Description
- EEG/EMG/EP System FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08056446900338 EUDAMEDFDA UDI
- Basic UDI-DI
- 080564469EMG_CN EUDAMED
- 510(k) Number
- K133517 FDA UDI
- FDA Product Code
- GWJ FDA UDIGWE FDA UDIGWF FDA UDIGWL FDA UDI
- EMDN Code
- Z121002 NERVOUS SYSTEM MONITORING SYSTEMS EUDAMED
- GMDN Term
- Evoked-potential graphic recording system FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 882.1900 FDA UDI882.1890 FDA UDI882.1870 FDA UDI882.1835 FDA UDI
- Market of Registration
- Italy 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
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
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
NeMus 2 by EB Neuro S.p.A. — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 080564469EMG_CN | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- EB Neuro S.p.A.
- EUDAMED SRN
- IT-MF-000027944
Sources (2)
- EUDAMED 1c6c8806-0efe-4a54-894b-5750879e49b2 61 fields · synced Jun 8, 2026
- FDA UDI 38a1cf8a-05f8-4b7f-b03c-278058c66c52 35 fields · synced May 30, 2026