BWIII Basics
Ref PV2010Model BWIII EEG
BWIII Basics (PV2010) is an electroencephalograph (EU MDR Class IIa; FDA Class II; FDA product code GWQ, Full-Montage Standard Electroencephalograph) made by Neurovirtual USA, Inc., registered in EUDAMED on 13 Apr 2026 (Basic UDI-DI 0850008393BWIIIEEGPT), cleared under FDA 510(k) K112107 on 28 Oct 2011 and listed in FDA GUDID since 26 Nov 2019 (UDI-DI 00850008393174), active as of 22 Oct 2026.
Active
Valid until
No date given
FDA recalls
None found
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number0850008393BWIIIEEGPT 00850008393174 | Date13 Apr 2026 | StatusActive |
| United States | GUDID listing GUDID | Number00850008393174 | Date26 Nov 2019 | StatusListed |
| United States | FDA 510(k)SESE GUDID | NumberK112107 | Date28 Oct 2011 | StatusActive |
Official records
- EUDAMED public site 0850008393BWIIIEEGPT
- AccessGUDID record 00850008393174
- FDA 510(k) database K112107
Across registries
- EUDAMED Basic UDI-DI 0850008393BWIIIEEGPT registered 13 Apr 2026 Active
- FDA 510(k) K112107 decided 28 Oct 2011 Active
- FDA GUDID UDI-DI 00850008393174 listed 26 Nov 2019 Listed
Timeline
- Cleared FDA 510(k) K112107
- Listed FDA GUDID 00850008393174
- Registered EUDAMED 0850008393BWIIIEEGPT
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade name
- BWIII Basics EUDAMEDNeurovirtual GUDID
- Generic name
- Electroencephalograph
- Device name
- Bwiii EEG
- Model / Ref / Catalog
- BWIII EEG, PV2010, BWIII Basics
- Primary DI / UDI-DI
- 00850008393174
- Basic UDI-DI
- 0850008393BWIIIEEGPT
- Direct marketing DI
- 00850008393174
- 510(k) Number
- FDA product code
- GWQ
- EMDN code
- Z12100303 Systems for analysing and managing EEG traces
- GMDN term
- Electroencephalograph
- Device class
- Class IIa EUDAMEDClass II GUDID
- Regulation number
- 882.1400
- System or procedure pack
- System which is a device in itself
- EU registration type
- Standard device
- EU market of registration
- Spain
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Model / reference | BWIII EEG PV2010 | BWIII Basics |
| Device class | Class IIa | Class II |
| Supplied sterile | Yes | No |
| Sterilise before use | Yes | No |
| Contains latex | Yes | No |
Registry differences
EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:
- Supplied sterile UDI-DI 00850008393174: EUDAMED states Yes, FDA GUDID states No.
- Sterilise before use UDI-DI 00850008393174: EUDAMED states Yes, FDA GUDID states No.
- Contains latex UDI-DI 00850008393174: EUDAMED states Yes, FDA GUDID states No.
Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.
Manufacturer details
- EUDAMED SRN
- US-MF-000042555
- Authorised representative
- Obelis s.a. BE-AR-000000106
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