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Venedig

by Anita Dr. Helbig GmbH

Ref L9-6214

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 Number4009706Y06309902ZQ Basic UDI-DI Date17 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  • Withdrawn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
Prosthetic swimwear
Model / Reference
L9-6214
Primary DI / UDI-DI
04058509207693, 04058509207495, 04058509207617, 04058509207655, 04058509207709, 04058509207587, 04058509207518, 04058509207594, 04058509207686, 04058509207488, 04058509207549, 04058509207471, 04058509207532, 04058509207631, 04058509207648, 04058509207624, 04058509207662, 04058509207525, 04058509207570, 04058509207679, 04058509207563, 04058509207600, 04058509207501, 04058509207556
Basic UDI-DI
4009706Y06309902ZQ
Direct Marketing DI
04058509207693
04058509207495
04058509207617
04058509207655
04058509207709
04058509207587
04058509207518
04058509207594
04058509207686
04058509207488
04058509207549
04058509207471
04058509207532
04058509207631
04058509207648
04058509207624
04058509207662
04058509207525
04058509207570
04058509207679
04058509207563
04058509207600
04058509207501
04058509207556
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