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SIMPLE Wrist brace W3

by Simple Medical (Shenzhen) Limited China EUDAMED

Ref 42001-LModel 31003,31004,31020,31302,30303,31501,31502,31801,31804,31805,31806,31807,31808,31809,31901,31906,30903,30904,41003,41004,41011,41012,41301,31001,31002,31010,31011,31012,31013,31014,31015,31017,31018,31019,31020,41009,42001,42003,42004,52301 EMDN Y060612

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697124454UpperExtremityXM Basic UDI-DIDate19 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Model / Reference
31003, 31004, 31020, 31302, 30303, 31501, 31502, 31801, 31804, 31805, 31806, 31807, 31808, 31809, 31901, 31906, 30903, 30904, 41003, 41004, 41011, 41012, 41301, 31001, 31002, 31010, 31011, 31012, 31013, 31014, 31015, 31017, 31018, 31019, 41009, 42001, 42003, 42004, 52301, 42001-L
Primary DI / UDI-DI
06971244541885
Basic UDI-DI
697124454UpperExtremityXM
Direct Marketing DI
06971244541885
EMDN Code
Y060612 Wrist-hand orthoses
Device Class
Class I
Market of Registration
Poland

Manufacturer details

EUDAMED SRN
CN-MF-000013198
Authorised representative
MedNet EC-REP GmbH DE-AR-000000002

Other devices from Simple Medical (Shenzhen) Limited

See all devices from Simple Medical (Shenzhen) Limited →

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 06971244541885|697124454UPPEREXTREMITYXM 61 fields · synced 25 Oct 2026