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Air Compression Therapy Device

by Sunnyou Medical Co., Ltd. China EUDAMED

Ref XY-K-LC-4Model XY-K-WIC-3, XY-K-WIC-4, XY-K-LC-4, XY-K-LC-5 EMDN Z120607

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberCN25/00000057 Date6 May 2026IssuedStatusActive expires 3 Jan 2030

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • CN25/00000057 Amended

    Quality management system EU MDR

    Notified body
    Notified body 1639
    Issued
    6 May 2026
    Expires
    3 Jan 2030
    Reason
    Mnf data change

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
XY-K-WIC-3, XY-K-WIC-4, XY-K-LC-4, XY-K-LC-5
Primary DI / UDI-DI
06970291643504
Basic UDI-DI
697029164XY-K-WICLCKC
Direct Marketing DI
06970291643504
EMDN Code
Z120607 Pneumatic compression equipment
Device Class
Class IIa
Market of Registration
Belgium

Manufacturer details

EUDAMED SRN
CN-MF-000001112
Authorised representative
Lotus NL B.V. NL-AR-000000121

Other devices from Sunnyou Medical Co., Ltd.

See all devices from Sunnyou Medical Co., Ltd. →

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 (1)

  • EUDAMED e81b1eb8-fcb9-4747-8a4d-12d1f1411b08 61 fields · synced 24 Oct 2026