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Idracare Vaginal Gel

by Procare Health Iberia SL EUDAMED

Active European Union

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD Number8437018976IDRF2 Basic UDI-DIDate21 Mar 2022RegisteredStatusActive
European UnionCE/MDR Number8437018976IDRF2 Basic UDI-DIDate21 Mar 2022RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD, CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
Idracare
Primary DI / UDI-DI
08437018976409, 08437018976430, 08436620080993
Basic UDI-DI
8437018976IDRF2, B-08437018976430, B-08437018976409
EMDN Code
U0803 Vaginal devices in the form of solutions/creams/ova/tablets
Device Class
Class IIb
Class I
Market of Registration
Spain
Hungary

Manufacturer details

EUDAMED SRN
ES-MF-000001950

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Properties

Other properties (13)

  • Sterile: No
  • 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