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Anti-Brucella abortus ELISA (IgM) EI 2189-9601 M

by EUROIMMUN Medizinische Labordiagnostika AG

Ref EI 2189-9601 MModel EI 2189 M

Active European Union. Also listed in GUDID (US), not in commercial distribution.

CE IVDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None, self-declared

Class I: no certifier involved

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/IVDD EUDAMED NumberB-04049016027577 Basic UDI-DI 04049016027577UDI-DIDate13 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04049016027577 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: not in commercial distribution

Certificates

0 certificates · EUDAMED

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

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade Name
Anti-Brucella abortus ELISA (IgM)
Generic Name
Multiple Brucella species immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
Model / Reference
EI 2189-9601 M, EI 2189 M
Primary DI / UDI-DI
04049016027577
Basic UDI-DI
B-04049016027577
FDA Product Code
GSM
EMDN Code
W0105011701 Brucella
GMDN Term
Multiple Brucella species immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
Device Class
Class IVD General EUDAMED
Class II GUDID
Regulation Number
866.3085
EU market of registration
Germany
GUDID distribution status
Not in Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IVD General
GUDID
Class II

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Properties

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

Other properties (15)

  • 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
  • Manufacturing Date: No