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EUROLINE-WB Anti-Echinococcus (IgG) DY 2321-4801-2 G

by EUROIMMUN Medizinische Labordiagnostika AG

Ref DY 2321-4801-2 GModel DY 2321-2 G

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

CE IVDR

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number4049016DY23212G6Z Basic UDI-DI 04049016161035UDI-DIDate9 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04049016161035 UDI-DI Date20 Oct 2025ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

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  • Withdrawn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

Trade Name
EUROLINE-WB Anti-Echinococcus (IgG)
Generic Name
Echinococcus granulosus/E. multilocularis immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Model / Reference
DY 2321-4801-2 G, DY 2321-2 G
Primary DI / UDI-DI
04049016161035
Basic UDI-DI
4049016DY23212G6Z
FDA Product Code
GPE
EMDN Code
W0105050204 Echinococcus
GMDN Term
Echinococcus granulosus/E. multilocularis immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Device Class
Class B EUDAMED
Class I GUDID
Regulation Number
866.3200
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class B
GUDID
Class I

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Properties

  • Single Use
  • Human Tissues
  • Animal Tissues
  • Microbial Substances
  • Professional Testing
  • Convenience Kit
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (14)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No