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VitalScreen Reagent 2

by FertiPro

Ref VITAL_2Model VITAL

VitalScreen Reagent 2 (VITAL_2) is a device classified as Class A in the EU and Class I in the US made by FertiPro, registered in EUDAMED on 1 Jun 2023 (Basic UDI-DI 5411967VITAL1ZS) and listed in FDA GUDID since 22 Aug 2018 (UDI-DI 05411967001774), 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 Number5411967VITAL1ZS Basic UDI-DI 05411967001774UDI-DIDate1 Jun 2023RegisteredStatusActive
United StatesGUDID listing GUDID Number05411967001774 UDI-DI Date22 Aug 2018ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 5411967VITAL1ZS registered 1 Jun 2023 Active
  • FDA GUDID UDI-DI 05411967001774 listed 22 Aug 2018 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 05411967001774
  2. Registered EUDAMED 5411967VITAL1ZS

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  • Withdrawn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
Biological stain IVD
Model / reference
VITAL, VITAL_2
Primary DI / UDI-DI
05411967001774
Basic UDI-DI
5411967VITAL1ZS
Direct marketing DI
05411967001774
FDA product code
LED
EMDN code
W01030708 Stain solutions (histology/cytology)
GMDN term
Biological stain IVD
Device class
Class A EUDAMED
Class I GUDID
Regulation number
864.1850
EU registration type
Standard device
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution
Size
Total Volume — 30 Milliliter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
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
BE-MF-000000313

Similar devices in this category

Other devices filed under STAIN SOLUTIONS (HISTOLOGY/CYTOLOGY).

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Properties

  • IVD kit
  • Professional testing
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (21, all answered No)