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Upper and lower limb active and passive motion assessment training instument

by Guangzhou Yikang Medical Equipment Industrial Co., Ltd. EUDAMED

Active European Union

Ref SL4I-1SModel SL4I-1

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697534359SL4IRA Basic UDI-DIDate27 Jul 2026RegisteredStatusActive

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  • Withdrawn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)
  • FI25/1008008 Supplemented

    Quality management system EU MDR

    Notified body
    SGS FIMKO OY 0598
    Issued
    15 Jul 2026
    Expires
    23 Jan 2030
    Reason
    Add device or group

Specification

EUDAMED

Device Name
Upper and lower limb active and passive motion assessment training instument
Model / Reference
SL4I-1, SL4I-1S
Primary DI / UDI-DI
06975343590294
Basic UDI-DI
697534359SL4IRA
Direct Marketing DI
06975343590294
EMDN Code
Z120603 Passive rehabilitative gymnastics equipment
Device Class
Class IIa
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000031955
Authorised representative
Share info GmbH DE-AR-000005132

Other devices from Guangzhou Yikang Medical Equipment Industrial Co., Ltd

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Properties

  • Measuring Function

Other properties (12)

  • 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
  • Incorporates Medicinal Product: No