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EOLO coverline

by Cardivais S.A. EUDAMED

Active European Union

Ref 4K1104, 4K1101, 4K1103, 4K1401, 4K1202, 4K1102, 4K1203, 4K1201

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number842965905794LW Basic UDI-DIDate18 Feb 2025RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
Inflation kits
Model / Reference
4K1104, 4K1101, 4K1103, 4K1401, 4K1202, 4K1102, 4K1203, 4K1201
Primary DI / UDI-DI
08429659016750, 08429659024328, 08429659016743, 08429659035348, 08429659021150, 08429659019652, 08429659024564, 08429659024311
Basic UDI-DI
842965905794LW
EMDN Code
C0104010280 Interventional coronary angiography devices - accessories
Device Class
Class IIa
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
ES-MF-000017980

Other devices from Cardivais S.A.

See all devices from Cardivais S.A. →

Properties

  • Sterile

Other properties (12)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No