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Sentinel

by VistaPath Biosystems, Inc.

Ref Sentinel V1

Sentinel V1 is a pathology information system application software (EU IVDR Class A; FDA Class I; FDA product code NVV) made by VistaPath Biosystems, Inc., registered in EUDAMED on 11 Apr 2024 (Basic UDI-DI 08600094581173) and listed in FDA GUDID since 1 May 2023 (UDI-DI 00860009458109), active as of 22 Oct 2026.

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

CE IVDR

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/IVDR EUDAMED Number08600094581173 Basic UDI-DI 00860009458109UDI-DIDate11 Apr 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number00860009458109 UDI-DI Date1 May 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08600094581173 registered 11 Apr 2024 Active
  • FDA GUDID UDI-DI 00860009458109 listed 1 May 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00860009458109
  2. Registered EUDAMED 08600094581173

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Generic name
Pathology information system application software
Model / reference
Sentinel V1 EUDAMED
1 GUDID
Primary DI / UDI-DI
00860009458109
Basic UDI-DI
08600094581173
FDA product code
NVV
EMDN code
W02069099 Various sample processing instruments - other
GMDN term
Pathology information system application software
Device class
Class A EUDAMED
Class I GUDID
Regulation number
862.2100
EU registration type
Standard device
EU market of registration
Northern Ireland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
Sentinel V1
GUDID
1
Device classEUDAMED
Class A
GUDID
Class I

Device class is stated on each registry's own scale: Class A in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Manufacturer details

EUDAMED SRN
US-MF-000039863
Authorised representative
Qualrep Services B.V. NL-AR-000000537

Similar devices in this category

Other devices filed under VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER.

Properties

  • Contains human tissues or cells
  • IVD instrument
  • New device
  • Premarket exempt
  • Serial number
Other properties (21, all answered No)