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Idracare Vaginal Gel

by Procare Health Iberia SL Spain EUDAMED

EMDN U0803

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberB-08437018976447 Basic UDI-DIDate4 May 2026RegisteredStatusActive
European UnionCE/MDD NumberB-08437018976447 Basic UDI-DIDate4 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR, CE/MDD Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Device Name
Idracare
Primary DI / UDI-DI
08437018976447
Basic UDI-DI
B-08437018976447, 8437018976IDRF2
EMDN Code
U0803 Vaginal devices in the form of solutions/creams/ova/tablets
Device Class
Class I
Class IIb
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
ES-MF-000001950

Other devices from Procare Health Iberia SL

See all devices from Procare Health Iberia SL →

Properties & raw data

Show properties, registry sources and raw records
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

Sources (2)

  • EUDAMED 3d03ce86-7f3c-4770-bcaf-4d5a08a40f54 61 fields · synced 25 Oct 2026
  • EUDAMED 08437018976447|8437018976IDRF2 61 fields · synced 25 Oct 2026