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CHROMagar™ KPC

by G. PAPANIKOLAOU & CO. LP - Bioprepare 2 variants

Ref 010385Model CHROMagar™ KPC 010385

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 linked in EUDAMED

A group certificate may exist

Trust

Unverified

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

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number52120377010385CU Basic UDI-DI 05212037700227UDI-DIDate31 Aug 2026RegisteredStatusActive

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

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Specification

EUDAMED

Model / Reference
CHROMagar™ KPC 010385, 010385
Primary DI / UDI-DI
05212037700227
Basic UDI-DI
52120377010385CU
EMDN Code
W0104010404 Chromogenic resistance marker media (plates) - mrsa, vre, esbl …
Device Class
Class A
EU market of registration
Greece

Manufacturer details

EUDAMED SRN
EL-MF-000055282

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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