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Sabouraud Dextrose LAB-AGAR™ with Chloramphenicol

by BioMaxima Spółka Akcyjna EUDAMED

Active European Union

Ref BT 5108.01

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number59026439ABSDCLHU Basic UDI-DIDate7 Jul 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  • Withdrawn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

Device Name
Sabouraud Dextrose with Chloramphenicol LAB-AGAR™
Model / Reference
BT 5108.01
Primary DI / UDI-DI
05902643948600
Basic UDI-DI
59026439ABSDCLHU, 59026439ASSDCCP5
EMDN Code
W0104010306 Culture media in bottles
Device Class
Class A
Market of Registration
Poland

Manufacturer details

EUDAMED SRN
PL-MF-000039473

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Properties

  • Animal Tissues NoEUDAMEDYesEUDAMED
  • Microbial Substances NoEUDAMEDYesEUDAMED
  • Professional Testing

Other properties (8)

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