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Athena Thigh Support

by Zhangpu Ortholife Rehabilitation Co., Ltd. 3 variants

Ref 512001(S/UNI/Blue)Model Athena Thigh Support:512001

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number47198728651WH Basic UDI-DI 04719872869139UDI-DIDate15 Apr 2026RegisteredStatusActive

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  • Withdrawn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

Device Name
Knee Brace (Thigh Support)
Model / Reference
Athena Thigh Support:512001, 512001(S/UNI/Blue)
Primary DI / UDI-DI
04719872869139
Basic UDI-DI
47198728651WH
EMDN Code
Y061217 Thigh orthoses
Device Class
Class I
EU market of registration
Ireland

Manufacturer details

EUDAMED SRN
CN-MF-000011447
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Zhangpu Ortholife Rehabilitation Co., Ltd.

See all devices from Zhangpu Ortholife Rehabilitation 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