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ankle support

by Yangzhou Jingba Sports Goods Co., Ltd. 3 variants

Ref 8341-GREYModel 7794,78008,7818,7811,7825,7847,7862，7405,7406,7407,7408,7409,7410,7443-7405,7411,4232,4222,4227,7414,7404,7402,7437,7400,7415,8003,8321,8330,8341,8342,8370,3007 or customized

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number693481704098HX Basic UDI-DIDate28 May 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No notified-body 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  • Withdrawn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
7794, 78008, 7818, 7811, 7825, 7847, 7862，7405, 7406, 7407, 7408, 7409, 7410, 7443-7405, 7411, 4232, 4222, 4227, 7414, 7404, 7402, 7437, 7400, 7415, 8003, 8321, 8330, 8341, 8342, 8370, 3007 or customized, 8341-GREY
Primary DI / UDI-DI
06934817000004
Basic UDI-DI
693481704098HX
EMDN Code
Y06120601 Passive ankle-foot orthoses
Device Class
Class I
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000033682
Authorised representative
Humiss Beratung GmbH DE-AR-000023447

Other devices from Yangzhou Jingba Sports Goods Co., Ltd.

See all devices from Yangzhou Jingba Sports Goods 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