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Vancomycin 30 (B) E112023

by BioMaxima Spółka Akcyjna 5 variants

Ref E112028 (K), E112028 (W), 0158B05

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 linked in EUDAMED

A group certificate may exist

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 Number59026439BASTVAMH Basic UDI-DI Date11 Jul 2025RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDR Active

Specification

EUDAMED

Trade Name
Vancomycin
Device Name
Vancomycin 30 (B) E112023
MIC test VANCOMYCIN
Model / Reference
E112028 (K), E112028 (W), 0158B05
Primary DI / UDI-DI
05902643979260, 05902643982260, 05902643971585
Basic UDI-DI
59026439BASTVAMH, 59026439BBMVAL3
EMDN Code
W0104080502, W0104080501
Device Class
Class B
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