Skip to content

Hazel

by Anita Dr. Helbig GmbH 26 variants

Ref 5765X

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  • Withdrawn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
5765X
Primary DI / UDI-DI
04058509435362, 04058509435140, 04058509435034, 04058509692369, 04058509435263, 04058509692642, 04058509435041, 04058509435201, 04058509435447, 04058509505485, 04058509435164, 04058509435065, 04058509435102, 04058509692338, 04058509692581, 04058509435003, 04058509435218, 04058509435027, 04058509435430, 04058509692321, 04058509435508, 04058509435249, 04058509692482, 04058509435133, 04058509505522, 04058509692543, 04058509435225, 04058509692628, 04058509505553, 04058509692673, 04058509435409, 04058509435171, 04058509505539
Basic UDI-DI
4009706Y06309901ZN
Direct Marketing DI
04058509435362
04058509435140
04058509435034
04058509692369
04058509435263
04058509692642
04058509435041
04058509435201
04058509435447
04058509505485
04058509435164
04058509435065
04058509435102
04058509692338
04058509692581
04058509435003
04058509435218
04058509435027
04058509435430
04058509692321
04058509435508
04058509435249
04058509692482
04058509435133
04058509505522
04058509692543
04058509435225
04058509692628
04058509505553
04058509692673
04058509435409
04058509435171
04058509505539
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