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Agar Hektoen Pentru Enterobacteri (Hektoen Enteric Agar)

by Sanimed International Impex S.A.

Ref 20299, 102925, 40295

Active European Union

CE IVDR

Valid until

Not listed

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number594054037AGARHEKTOENP23UK Basic UDI-DI Date13 Nov 2025RegisteredStatusActive

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  • Withdrawn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/IVDR Active

Specification

EUDAMED

Model / Reference
20299, 102925, 40295
Primary DI / UDI-DI
05940540375167, 05940540375150, 05940540375174
Basic UDI-DI
594054037AGARHEKTOENP23UK, 594054037AGARHEKTOENP12UE, 594054037AGARHEKTOENP34UQ
EMDN Code
W0104010405, W0104010306, W0104010101
Device Class
Class A
EU market of registration
Romania

Manufacturer details

EUDAMED SRN
RO-MF-000035897

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Properties

  • Reagent
  • Professional Testing

Other properties (9)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No