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BWMini HST Compass

by Neurovirtual USA Inc

Ref SI1842Model BWMini HST Compass

BWMini HST Compass (SI1842) is a polysomnograph (EU MDR Class IIa; FDA Class II; FDA product code OLV, Standard Polysomnograph With Electroencephalograph) made by Neurovirtual USA, Inc., registered in EUDAMED on 3 Jul 2024 (Basic UDI-DI 0850008393SI1842Q8) and listed in FDA GUDID since 26 Nov 2019 (UDI-DI 00850008393259), active as of 22 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0850008393SI1842Q8 Basic UDI-DI 00850008393259UDI-DIDate3 Jul 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number00850008393259 UDI-DI Date26 Nov 2019ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0850008393SI1842Q8 registered 3 Jul 2024 Active
  • FDA GUDID UDI-DI 00850008393259 listed 26 Nov 2019 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00850008393259
  2. Registered EUDAMED 0850008393SI1842Q8

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
BWMini HST Compass EUDAMED
Neurovirtual GUDID
Generic name
Polysomnograph
Model / Ref / Catalog
BWMini HST Compass, SI1842
Primary DI / UDI-DI
00850008393259
Basic UDI-DI
0850008393SI1842Q8
Direct marketing DI
00850008393259
FDA product code
OLV
EMDN code
Z12100303 Systems for analysing and managing EEG traces
GMDN term
Polysomnograph
Device class
Class IIa EUDAMED
Class 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

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

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

Similar devices in this category

Other devices filed under ELECTROENCEPHALOGRAPHY INSTRUMENTS.

Other devices from Neurovirtual USA, Inc.

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Properties

  • Measuring function
  • Prescription use
  • Serial number
Other properties (22, all answered No)