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Upper and lower limb active and passive motion assessment training instument

by Guangzhou Yikang Medical Equipment Industrial Co., Ltd.

Ref Model : SL4I-1Model SL4I-1

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

23 Jan 2030

CE MDR certificate

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

1 certificate

Certifier SGS FIMKO OY

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number697534359SL4IRA Basic UDI-DI 06975343590287UDI-DIDate27 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06975343590287 UDI-DI Date14 May 2026ListedStatusListed GUDID: in commercial distribution

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • FI25/1008008 Active Supplemented

    Quality management system EU MDR

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

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Upper and lower limb active and passive motion assessment training instrument
Generic Name
Biomechanical function analysis system, force-testing, portable
Device Name
Upper and lower limb active and passive motion assessment training instument
Model / Reference
SL4I-1, Model : SL4I-1
Primary DI / UDI-DI
06975343590287
Basic UDI-DI
697534359SL4IRA
Direct Marketing DI
06975343590287
FDA Product Code
IKK
EMDN Code
Z120603 Passive rehabilitative gymnastics equipment
GMDN Term
Biomechanical function analysis system, force-testing, portable
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
890.1925
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

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
  • Premarket Exempt
  • Serial Number
  • Manufacturing Date

Other properties (20)

  • Sterile: No
  • Single Use: 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
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Lot / Batch Number: No
  • Expiration Date: No