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H.e / S.s / X.L.D. Agar

by Sundial Co. Ltd Cyprus EUDAMED

Ref SUN30270 EMDN W0104010407

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number5298004040138Y5 Basic UDI-DIDate30 Mar 2026RegisteredStatusActive

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  • Withdrawn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 25 Oct 2026

Device Name
H.e / S.S. / X.L.D. Agar
Model / Reference
SUN30270
Primary DI / UDI-DI
05298004040138
Basic UDI-DI
5298004040138Y5
EMDN Code
W0104010407 Bi-plates - including non-chromogenic & chromogenic media combination
Device Class
Class A
Market of Registration
Cyprus

Manufacturer details

EUDAMED SRN
CY-MF-000023765

Other devices from Sundial Co. Ltd

See all devices from Sundial Co. Ltd →

Properties & raw data

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

Sources (1)

  • EUDAMED 0ff3ef7c-1d85-45f5-9197-3cb2e7d5cef9 61 fields · synced 25 Oct 2026