Identity
- Trade Name
- BWMini EEG EUDAMEDNeurovirtual FDA UDI
- Generic Name
- Electroencephalograph FDA UDI
- Device Name
- BWMini EEG EUDAMEDElectroencephalograph BWMini EEG FDA UDI
- Model / Reference
- BWMini EEG EUDAMEDFDA UDIPV2310 EUDAMED
- Description
- Electroencephalograph BWMini EEG FDA UDI
Identifiers
- Catalog Number
- PV2310 FDA UDI
- Primary DI / UDI-DI
- 00850008393235 EUDAMEDFDA UDI
- Basic UDI-DI
- 0850008393PV2310SH EUDAMED
- Direct Marketing DI
- 00850008393235 EUDAMED
- FDA Product Code
- GWQ FDA UDI
- EMDN Code
- Z12100303 SYSTEMS FOR ANALYSING AND MANAGING EEG TRACES EUDAMED
- GMDN Term
- Electroencephalograph FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 882.1400 FDA UDI
- Market of Registration
- Spain 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
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
No
FDA UDI
MR Unsafe FDA UDI
BWMini EEG by Neurovirtual Usa, Inc. — Class IIa — 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 | 0850008393PV2310SH | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Neurovirtual USA Inc
- EUDAMED SRN
- US-MF-000042555
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (2)
- EUDAMED e9c82868-8afe-4ac3-b398-4d2cba0b65aa 61 fields · synced Aug 4, 2026
- FDA UDI dab0415a-5518-4581-bbae-e02150a7081b 35 fields · synced May 30, 2026