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Trypticasein Soy LAB-AGAR™

by BioMaxima Spółka Akcyjna 5 variants

Ref BT 5000.01, BT 5000.02, PP 1180, PP 0118

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 Number59026439ABTSALJ 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  • Withdrawn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

Device Name
Trypticasein Soy LAB-AGAR™ (d140)
Trypticasein Soy LAB-AGAR™ (TSA)
Model / Reference
BT 5000.01, BT 5000.02, PP 1180, PP 0118
Primary DI / UDI-DI
05902643949508, 05902643949515, 05902643930537, 05902643931855
Basic UDI-DI
59026439ABTSALJ, 59026439APTSAPL, 59026439ASTSAQ9
EMDN Code
W0104010306, W0104010405
Device Class
Class A
EU 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