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Ankle support

by Yangzhou Sensport Healthcare Supplies Co., Ltd 5 variants

Ref BM-AK2505-GR-XLModel BM-AK1099,BM-AN1097, BM-AP1098,BM-AK2302,BM-AK2301, BM-AK-2308,BM-AK2303,BM- AK2403,BM-AK2401，BM-AK2505

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697467894BM-AKQG Basic UDI-DIDate17 Sep 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  • Withdrawn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

Device Name
Ankle support
Model / Reference
BM-AK1099, BM-AN1097, BM-AP1098, BM-AK2302, BM-AK2301, BM-AK-2308, BM-AK2303, BM- AK2403, BM-AK2401，BM-AK2505, BM-AK2505-GR-XL
Primary DI / UDI-DI
06974678940200
Basic UDI-DI
697467894BM-AKQG
EMDN Code
Y06120602 Energy return ankle-foot orthoses
Device Class
Class I
Market of Registration
Poland

Manufacturer details

EUDAMED SRN
CN-MF-000057824
Authorised representative
Humiss Beratung GmbH DE-AR-000023447

Other devices from Yangzhou Sensport Healthcare Supplies Co., Ltd

See all devices from Yangzhou Sensport Healthcare Supplies 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