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EpiScreen Plus Reagent 4

by FertiPro

Ref EPI_PLUS_4Model EPI_PLUS

EpiScreen Plus Reagent 4 (EPI_PLUS_4) is a Class B device made by FertiPro, registered in EUDAMED on 25 May 2023 (Basic UDI-DI 5411967EPIP1VD), active as of 25 Oct 2026.

Active European Union

CE IVDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number5411967EPIP1VD Basic UDI-DI 05411967001651UDI-DIDate25 May 2023RegisteredStatusActive

Official records

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDR Active

Specification

EUDAMED

Device name
EpiScreen Plus
Model / reference
EPI_PLUS, EPI_PLUS_4
Primary DI / UDI-DI
05411967001651
Basic UDI-DI
5411967EPIP1VD
Direct marketing DI
05411967001651
EMDN code
W01010199 Enzymes - other
Device class
Class B
EU registration type
Standard device
EU market of registration
Belgium

Manufacturer details

EUDAMED SRN
BE-MF-000000313

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Other devices filed under ENZYMES - OTHER.

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Properties

  • Reagent
  • IVD kit
  • Professional testing
Other properties (10, all answered No)