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Sabouraud Dextrose with Chloramphenicol and Gentamicin LAB-AGAR™

by BioMaxima Spółka Akcyjna 2 variants

Ref BT 5142.01, PS 248- 500, PW 3206, BT 5142.05, PP 1232, PW 3323S, PW 3323

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 Number59026439ABSDCGHJ Basic UDI-DI Date7 Jul 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  • Withdrawn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

Trade Name
Sabouraud Dextrose with Chloramphenicol and Gentamicin LAB-AGAR™
Sabouraud Dextrose with Chloramphenicol and Gentamycin LAB-AGAR™
Device Name
Sabouraud Dextrose w.Chloramphenicol and Gentamycin LAB-AGAR™
Sabouraud Dextrose with Chloramphenicol and Gentamicin LAB-AGAR™ /skos/slant
Sabouraud Dextrose with Chloramphenicol and Cycloheximide LAB-AGAR™
Model / Reference
BT 5142.01, PS 248- 500, PW 3206, BT 5142.05, PP 1232, PW 3323S, PW 3323
Primary DI / UDI-DI
05902643948662, 05902643908857, 05902643939875, 05902643950368, 05902643930308, 05902643941939, 05902643941922
Basic UDI-DI
59026439ABSDCGHJ, 59026439ASSDCLPP, 59026439ATSDCHGTF, 59026439APSDCGNC, 59026439ASSDCHPF
EMDN Code
W0104010306, W0104010101, W0104010206, W0104010405
Device Class
Class A
EU 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