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Selca

by Fundación CARTIF EUDAMED

Active European Union

Ref 8435814800034-SA-BL, 8435814800003-SI-WH, 8435814800010-SA-GR

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number84358148000345N Basic UDI-DIDate19 Jun 2025RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates

0 certificates · EUDAMED

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Specification

EUDAMED

Device Name
Selca Andin Negro
Selca Inotec
Selca Andin Verde
Model / Reference
8435814800034-SA-BL, 8435814800003-SI-WH, 8435814800010-SA-GR
Primary DI / UDI-DI
08435814800034, 08435814800003, 08435814800010
Basic UDI-DI
84358148000345N, 84358148000035B, 843581480001058
EMDN Code
Y120603, Y180999
Device Class
Class I
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
ES-MF-000048251

Other devices from Fundación CARTIF

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