Skip to content

Skywalk

by autonomyo Sàrl EUDAMED

Active European Union

Ref SKW-001-EUModel Clinic Adult 1.0

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD Number76499881341TDskywalkCASV Basic UDI-DIDate8 Oct 2026RegisteredStatusActive
European UnionCE/MDR Number76499881341TDskywalkCASV Basic UDI-DIDate8 Oct 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD, 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
Skywalk
Model / Reference
Clinic Adult 1.0, SKW-001-EU
Primary DI / UDI-DI
76499881341358
Basic UDI-DI
76499881341TDskywalkCASV, B-76499881341358
Direct Marketing DI
76499881341358
EMDN Code
Y050201 Standing support gait trainers
Device Class
Class I
Market of Registration
France

Manufacturer details

EUDAMED SRN
CH-MF-000058520
Authorised representative
PureCE B.V. NL-AR-000006069

Properties

  • Contains Latex

Other properties (12)

  • Sterile: No
  • Implantable: No
  • Reusable: 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