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Clostridium difficile LAB-AGAR™ Base

by BioMaxima Spółka Akcyjna 3 variants

Ref PS 176- 100, PP 0004

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 Number59026439ASC_DIPP Basic UDI-DI Date31 Oct 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  • Withdrawn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
Clostridium difficile LAB-AGAR™ Base
Clostridium difficile LAB-AGAR™
Model / Reference
PS 176- 100, PP 0004
Primary DI / UDI-DI
05902643914971, 05902643929395
Basic UDI-DI
59026439ASC_DIPP
EMDN Code
W0104010101, W0104010405
Device Class
Class A
EU market of registration
Poland

Manufacturer details

EUDAMED SRN
PL-MF-000039473

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Properties

  • Animal Tissues
  • Microbial Substances
  • 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