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Cover Outer Axiom SP Fluid

by Ki Mobility LLC EUDAMED

Active European Union

Ref XSPC1622FModel Seating

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number08403633SEATINGK7 Basic UDI-DIDate21 Aug 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  • Withdrawn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

Model / Reference
Seating, XSPC1622F
Primary DI / UDI-DI
00840363380254
Basic UDI-DI
08403633SEATINGK7
EMDN Code
V080399 Medical cushions - other
Device Class
Class I
Market of Registration
Sweden

Manufacturer details

EUDAMED SRN
US-MF-000012633
Authorised representative
Etac Supply Center AB SE-AR-000001601

Other devices from Ki Mobility, LLC

See all devices from Ki Mobility, LLC →

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