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REAL RESPIRATORY BACTERIAL PANEL 2 (B. pertussis, B. parapertussis, B. holmesii) (Code/código: 5.182.XXX.88.ZZZ)

by Operon, S.A. Spain EUDAMED

Ref 5.182.096.88.000Model 5.182.XXX.88.ZZZ

EMDN W0105011607

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number84295775182XE Basic UDI-DIDate14 Apr 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
REAL RESPIRATORY BACTERIAL PANEL 2 (B. pertussis, B. parapertussis, B. holmesii)
Model / Reference
5.182.XXX.88.ZZZ, 5.182.096.88.000
Primary DI / UDI-DI
08429577003122
Basic UDI-DI
84295775182XE
EMDN Code
W0105011607 Bordetella pertussis / parapertussis - na reagents
Device Class
Class B
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
ES-MF-000004790

Other devices from Operon, S.A.

See all devices from Operon, S.A. →

Properties & raw data

Show properties, registry sources and raw records
  • Microbial Substances
  • Reagent
  • Professional Testing
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED fea064b5-9a98-4479-847f-84de2ae4535e 61 fields · synced 22 Oct 2026