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Wheelchair

by Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. 29 variants

Ref K2Model H083 1100A H011 Y103 TC06 TC05 TC03 TC02 TC01 EC03 EC01 N001 2001D 2001 DS03 DS02 DS01 K3 K2 H035 LH010 H005A HK3 SE28 K7 EC02 2002 H058B H009B H080C SW01 TC04 K4 K1 H065C H062C H062 H010 H004 E1 C2600 SC02 SC01 KW01 H102 H067C H067 H066C H066 H060C H060

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K120526↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number693325792369JP Basic UDI-DI 06933257948211UDI-DIDate4 Mar 2026RegisteredStatusActive
United StatesFDA 510(k) 510(k) NumberK120526 Date8 Mar 2012IssuedStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 24 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • United States FDA 510(k) Active
  • European Union CE/MDR Active

Specification

EUDAMED · 510(k)

Model / Reference
H083 1100A H011 Y103 TC06 TC05 TC03 TC02 TC01 EC03 EC01 N001 2001D 2001 DS03 DS02 DS01 K3 K2 H035 LH010 H005A HK3 SE28 K7 EC02 2002 H058B H009B H080C SW01 TC04 K4 K1 H065C H062C H062 H010 H004 E1 C2600 SC02 SC01 KW01 H102 H067C H067 H066C H066 H060C H060, K2
Primary DI / UDI-DI
06933257948211
Basic UDI-DI
693325792369JP
Direct Marketing DI
06933257948211
EMDN Code
Y122103 Push wheelchairs
Device Class
Class I
EU market of registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000012834
Authorised representative
Metrax GmbH DE-AR-000005481

Other devices from Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.

See all devices from Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. →

Properties

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