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CHROMagar™ CANDIDA Plus - CHROMagar™ ESBL – CHROMagar™ KPC

by G. PAPANIKOLAOU & CO. LP - Bioprepare EUDAMED

Active European Union

Ref 030877Model CHROMagar™ CANDIDA Plus - CHROMagar™ ESBL – CHROMagar™ KPC

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number52120377030877EC Basic UDI-DIDate2 Sep 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDR Active

Certificates

0 certificates · EUDAMED

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

Specification

EUDAMED

Device Name
030877
Model / Reference
CHROMagar™ CANDIDA Plus - CHROMagar™ ESBL – CHROMagar™ KPC, 030877
Primary DI / UDI-DI
05212037704454
Basic UDI-DI
52120377030877EC
EMDN Code
W0104010404 Chromogenic resistance marker media (plates) - mrsa, vre, esbl …
Device Class
Class A
Market of Registration
Greece

Manufacturer details

EUDAMED SRN
EL-MF-000055282

From the manufacturer

Manufacturer's product page: CHROMagar

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Properties

  • Sterile
  • Reagent
  • Professional Testing

Other properties (8)

  • 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