Skip to content

EUROPLUS ANA Screen version 4 EUROPattern

by EUROIMMUN Medizinische Labordiagnostika AG 4 variants

Ref FW 0805-1250-4Model FW 0805-4

Active European Union

CE IVDD

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 7 Nov 2026. What this means

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-04049016152538 Basic UDI-DI 04049016152538UDI-DIDate26 Oct 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Active

Specification

EUDAMED

Model / reference
FW 0805-4, FW 0805-1250-4
Primary DI / UDI-DI
04049016152538
Basic UDI-DI
B-04049016152538
EMDN code
W0102109099 Auto-immune disease tests - other
Device class
Class IVD General
EU registration type
Legacy device (under a directive)
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000005296

Other devices from EUROIMMUN Medizinische Labordiagnostika AG

See all devices from EUROIMMUN Medizinische Labordiagnostika AG →

Properties

  • Contains human tissues or cells
  • Contains animal tissues or cells
  • IVD kit
  • Professional testing

Other properties (9)

  • Supplied sterile: No
  • Sterilise before use: No
  • Contains substances of microbial origin: No
  • Reagent: No
  • Self-testing: No
  • Near-patient testing: No
  • Companion diagnostics: No
  • IVD instrument: No
  • New device: No