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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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 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  • Withdrawn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
04058509292071, 04058509292088, 04058509292194, 04058509291821, 04058509338328, 04058509338151, 04058509292132, 04058509291883, 04058509291968, 04058509291739, 04058509291975, 04058509338113, 04058509291692, 04058509291951, 04058509338175, 04058509292026, 04058509338083, 04058509338250, 04058509338335, 04058509338229, 04058509338236, 04058509338243, 04058509291937, 04058509292163, 04058509338182, 04058509291852, 04058509292217, 04058509338298, 04058509291999, 04058509291807, 04058509292187, 04058509291814, 04058509291944, 04058509338281, 04058509291647, 04058509291623, 04058509291982, 04058509338106, 04058509291654, 04058509338342, 04058509338304, 04058509291678, 04058509291913, 04058509291753, 04058509292040, 04058509338311, 04058509291715, 04058509292125, 04058509292156, 04058509291777, 04058509291708
Basic UDI-DI
4009706Y06309901ZN
Direct Marketing DI
04058509292071
04058509292088
04058509292194
04058509291821
04058509338328
04058509338151
04058509292132
04058509291883
04058509291968
04058509291739
04058509291975
04058509338113
04058509291692
04058509291951
04058509338175
04058509292026
04058509338083
04058509338250
04058509338335
04058509338229
04058509338236
04058509338243
04058509291937
04058509292163
04058509338182
04058509291852
04058509292217
04058509338298
04058509291999
04058509291807
04058509292187
04058509291814
04058509291944
04058509338281
04058509291647
04058509291623
04058509291982
04058509338106
04058509291654
04058509338342
04058509338304
04058509291678
04058509291913
04058509291753
04058509292040
04058509338311
04058509291715
04058509292125
04058509292156
04058509291777
04058509291708
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