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Versailles

by Anita Dr. Helbig GmbH 48 variants

Ref 5777X

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 Number4009706Y06309901ZN Basic UDI-DI Date15 Jun 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  • Withdrawn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
Accessories
Model / Reference
5777X
Primary DI / UDI-DI
04009706971641, 04009706391067, 04009706194439, 04009706390930, 04009706194521, 04009706971702, 04009706194484, 04009706971498, 04009706199533, 04009706194576, 04009706390947, 04009706971559, 04009706391050, 04009706199465, 04009706194514, 04009706391081, 04009706971658, 04009706971603, 04009706199540, 04009706194569, 04009706362418, 04009706971573, 04009706199458, 04009706390893, 04009706971450, 04009706362562, 04009706362425, 04009706194491, 04009706194392
Basic UDI-DI
4009706Y06309901ZN
Direct Marketing DI
04009706971641
04009706391067
04009706194439
04009706390930
04009706194521
04009706971702
04009706194484
04009706971498
04009706199533
04009706194576
04009706390947
04009706971559
04009706391050
04009706199465
04009706194514
04009706391081
04009706971658
04009706971603
04009706199540
04009706194569
04009706362418
04009706971573
04009706199458
04009706390893
04009706971450
04009706362562
04009706362425
04009706194491
04009706194392
EMDN Code
Y063099 Non-extremity prostheses - other
Device Class
Class I
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
DE-MF-000012631

Other devices from Anita Dr. Helbig GmbH

See all devices from Anita Dr. Helbig GmbH →

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