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Wheelchair

by Danyang Sunco Machinery Co.ltd China EUDAMED

Ref SKW8026Model SKW8001、SKW8001-12、SKW8002、SKW8002A、SKW8002B、SKW8002C、SKW8002D、SKW8003、SKW8004、SKW8005、SKW8006、SKW8008、SKW8009、SKW8010、SKW8012、SKW8020、etc

EMDN Y122103

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697943686WheelchairX8 Basic UDI-DIDate31 Dec 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Device Name
Wheelchair
Model / Reference
SKW8001、SKW8001-12、SKW8002、SKW8002A、SKW8002B、SKW8002C、SKW8002D、SKW8003、SKW8004、SKW8005、SKW8006、SKW8008、SKW8009、SKW8010、SKW8012、SKW8020、etc, SKW8026
Primary DI / UDI-DI
06979436860219
Basic UDI-DI
697943686WheelchairX8
EMDN Code
Y122103 Push wheelchairs
Device Class
Class I
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000051111
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Danyang Sunco Machinery Co.ltd

See all devices from Danyang Sunco Machinery 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 54ce38c4-23aa-4d93-96af-06d41690e2ba 61 fields · synced 23 Oct 2026