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Blood Sample Collection Kit for the Harmony Test

by Ayala Sample Kits, S.L. Spain EUDAMED

Ref CAL011.085Model CAL004.1, CAL011.01, CAL011.02, CAL011.03, CAL011.04, CAL011.05, CAL011.06, CAL011.07, CAL011.08, CAL011.081, CAL011.082, CAL011.083, CAL011.084, CAL011.085,ETC EMDN W05019099

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number843662829BLY7 Basic UDI-DIDate14 Jul 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  • Withdrawn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 23 Oct 2026

Device Name
Kit De Extracción De Sangre
Model / Reference
CAL004.1, CAL011.01, CAL011.02, CAL011.03, CAL011.04, CAL011.05, CAL011.06, CAL011.07, CAL011.08, CAL011.081, CAL011.082, CAL011.083, CAL011.084, CAL011.085, ETC
Primary DI / UDI-DI
08436628290257
Basic UDI-DI
843662829BLY7
EMDN Code
W05019099 Samples collection devices - other
Device Class
Class A
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
ES-MF-000037853

Other devices from Ayala Sample Kits, S.L.

See all devices from Ayala Sample Kits, S.L. →

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 589d3726-06b1-4127-b889-85b311d9105a 61 fields · synced 23 Oct 2026