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Reinforced universal set

by Cardivais S.A. EUDAMED

Active European Union

Ref 16110000, 12201501, 16100202, 12002220

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number842965905809LJ Basic UDI-DIDate16 Jan 2026RegisteredStatusActive

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  • Withdrawn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

Trade Name
Reinforced universal set
coverline
Surgical drape (IS) 50x50cm
Standard Surgical Gown SMMMS size "M"
Device Name
Surgical Sets
Protective gowns
Surgical drapes
Surgical gowns
Model / Reference
16110000, 12201501, 16100202, 12002220
Primary DI / UDI-DI
08429659006003, 08429659002050, 08429659004450, 08429659009059
Basic UDI-DI
842965905809LJ, 842965905804L8, 842965905806LC, 842965905805LA
Direct Marketing DI
08429659006003
08429659004450
08429659009059
EMDN Code
T0203, T0205, T020199, T020499
Device Class
Class I
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