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Respiratory Antigens Negative Control

by BioMaxima Spółka Akcyjna Poland EUDAMED

Ref 1-868-0001 EMDN W0105080899

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number59026439BRTK868QZ Basic UDI-DIDate22 Jul 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Device Name
Respiratory Antigens Negative Control
Model / Reference
1-868-0001
Primary DI / UDI-DI
05902643958876
Basic UDI-DI
59026439BRTK868QZ
EMDN Code
W0105080899 Controls - inf. immunology - other
Device Class
Class B
Market of Registration
Poland

Manufacturer details

EUDAMED SRN
PL-MF-000039473

Other devices from BioMaxima Spółka Akcyjna

See all devices from BioMaxima Spółka Akcyjna →

Properties & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED bb9abacf-13e6-451b-892e-05a28bce8d5d 61 fields · synced 23 Oct 2026