Identity
- Trade Name
- BWIII PSG Plus EUDAMEDNeurovirtual FDA UDI
- Generic Name
- Electroencephalograph FDA UDI
- Device Name
- BWIII PSG EUDAMEDBWIII PSG Plus: Full-montage standard electroencephalograph device FDA UDIPolysomnograph and Electroencephalograph BWIII PSG Plus FDA UDI
- Model / Reference
- BWIII PSG EUDAMEDPV2009 EUDAMEDBWIII PSG Plus FDA UDI
- Description
- BWIII PSG Plus: Full-montage standard electroencephalograph device FDA UDIPolysomnograph and Electroencephalograph BWIII PSG Plus FDA UDI
Identifiers
- Catalog Number
- PV 2009 FDA UDIPV2009 FDA UDI
- Primary DI / UDI-DI
- 00867975000202 EUDAMEDFDA UDI00850008393211 FDA UDI
- Basic UDI-DI
- 0850008393BWIIIPSGSU EUDAMED
- Direct Marketing DI
- 00867975000202 EUDAMED
- 510(k) Number
- K112107 FDA UDI
- FDA Product Code
- OLV FDA UDIGWQ 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
No
FDA UDIFDA 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
BWIII PSG Plus 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 | 0850008393BWIIIPSGSU | 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 (3)
- EUDAMED c857ee13-dbc3-42a0-9842-bfe2fbaa74a7 61 fields · synced Jun 8, 2026
- FDA UDI 5a3bf324-08ab-4852-b2d5-14af9547dfce 36 fields · synced May 30, 2026
- FDA UDI 0043059e-c816-4059-be7b-9ebaae83e4e1 36 fields · synced May 30, 2026