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Manual Wheelchair

by INTCO MEDICAL (HK) CO., ltd 133 variants

Ref R224, SDMSTAR 009, DM-312 - 20'', Coyote T, YK9080, YK9022, YK9032 17" black, DM-BOSS, DM-9081 Procare 40cm, R225 16", YK9140, DM-312 Pro 45cm, YK9090, YK9101, R255, KBE-9031KD, R213, YK9073, YK9032 16" black, DM-312 - 14'', GY410095, 43235, DM-312 35cm, CR1, Y12, Coyote A, R358, R221, DM-337 45cm, R214, Coyote M, DM-303 - 20'', Coyote R, R201, SDMSTAR 010, DM-312 - 18'', DM-337 50cm, DM-327 50cm, KP-Ⅱ, Coyote steel, YK9068, YK9031-1, YK9000 SERIE: 1, R222, YK9032 18", YK9032 17", DM-8001 35cmModel YK9000series

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

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

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number489712866-0-MWheelchairX2 Basic UDI-DI Date1 Dec 2023RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Model / Reference
YK9000series, R224, SDMSTAR 009, DM-312 - 20'', Coyote T, YK9080, YK9022, YK9032 17" black, DM-BOSS, DM-9081 Procare 40cm, R225 16", YK9140, DM-312 Pro 45cm, YK9090, YK9101, R255, KBE-9031KD, R213, YK9073, YK9032 16" black, DM-312 - 14'', GY410095, 43235, DM-312 35cm, CR1, Y12, Coyote A, R358, R221, DM-337 45cm, R214, Coyote M, DM-303 - 20'', Coyote R, R201, SDMSTAR 010, DM-312 - 18'', DM-337 50cm, DM-327 50cm, KP-Ⅱ, Coyote steel, YK9068, YK9031-1, YK9000 SERIE: 1, R222, YK9032 18", YK9032 17", DM-8001 35cm
Primary DI / UDI-DI
04897128666159, 04897128666654, 04897128665008, 04895272900549, 04897128666142, 04897128669839, 04897128667149, 04897128665879, 04897128667828, 04895272900662, 04897128666777, 04897128669846, 04895272900693, 04897128667545, 04897128667484, 04897128666210, 04897128668276, 04897128666104, 04897128667538, 04897128665862, 04897128664971, 04897128667095, 04895272901164, 04897128667682, 04897128669501, 04897128662885, 04895272900327, 04897128666036, 04897128665992, 04897128667767, 04897128666722, 04895272900495, 04897128665022, 04895272900501, 04897128665954, 04897128666197, 04897128666661, 04897128664995, 04897128666029, 04897128667774, 04897128666937, 04895272900815, 04895272900471, 04897128667378, 04895272900624, 04897128669938, 04897128669907, 04897128666098, 04897128665800, 04897128665794, 04897128668412
Basic UDI-DI
489712866-0-MWheelchairX2
Direct Marketing DI
04897128666159
04897128666654
04897128665008
04895272900549
04897128666142
04897128669839
04897128667149
04897128665879
04897128667828
04895272900662
04897128666777
04897128669846
04895272900693
04897128667545
04897128667484
04897128666210
04897128668276
04897128666104
04897128667538
04897128665862
04897128664971
04897128667095
04895272901164
04897128667682
04897128669501
04895272900327
04897128666036
04897128665992
04897128667767
04897128666722
04895272900495
04897128665022
04895272900501
04897128665954
04897128666197
04897128666661
04897128664995
04897128666029
04897128667774
04897128666937
04895272900815
04895272900471
04897128667378
04895272900624
04897128669938
04897128669907
04897128666098
04897128665800
04897128665794
04897128668412
EMDN Code
Y122106, Y122103
Device Class
Class I
EU market of registration
Türkiye
Austria
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000011338
Authorised representative
MedNet EC-REP GmbH DE-AR-000000002

Other devices from INTCO MEDICAL (HK) CO., ltd

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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