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MacConkey LAB-AGAR™

by BioMaxima Spółka Akcyjna EUDAMED

Active European Union

Ref PS 10- 25KG, BT 5010.02, BT 5010.01, PS 10- 5KG

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number59026439ASMACCMC Basic UDI-DIDate30 Oct 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • 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

Model / Reference
PS 10- 25KG, BT 5010.02, BT 5010.01, PS 10- 5KG
Primary DI / UDI-DI
05902643924604, 05902643947092, 05902643947108, 05902643924796
Basic UDI-DI
59026439ASMACCMC, 59026439ABMACCFH
EMDN Code
W0104010101, W0104010306
Device Class
Class A
Market of Registration
Poland

Manufacturer details

EUDAMED SRN
PL-MF-000039473

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Properties

  • Professional Testing

Other properties (10)

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