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Hanni

by Anita Dr. Helbig GmbH 20 variants

Ref 5787X

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  • Withdrawn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
5787X
Primary DI / UDI-DI
04058509292033, 04058509291845, 04058509292064, 04058509291685, 04058509291838, 04058509338373, 04058509338137, 04058509291661, 04058509291630, 04058509291869, 04058509291760, 04058509338090, 04058509291746, 04058509292101, 04058509292002, 04058509338359, 04058509291890, 04058509338274, 04058509338199, 04058509291876
Basic UDI-DI
4009706Y06309901ZN
Direct Marketing DI
04058509292033
04058509291845
04058509292064
04058509291685
04058509291838
04058509338373
04058509338137
04058509291661
04058509291630
04058509291869
04058509291760
04058509338090
04058509291746
04058509292101
04058509292002
04058509338359
04058509291890
04058509338274
04058509338199
04058509291876
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