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by Anita Dr. Helbig GmbH 5 variants

Ref M7-6505-1

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

Austria
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

  • Austria

Specification

EUDAMED

Device Name
Prosthetic swimwear
Model / Reference
M7-6505-1
Primary DI / UDI-DI
04058509870507, 04058509870477, 04058509870552, 04058509870460, 04058509870484, 04058509870521, 04058509870668, 04058509870576, 04058509870637, 04058509870606, 04058509870644, 04058509870675, 04058509870569, 04058509870446, 04058509870590, 04058509870545, 04058509870613, 04058509870651, 04058509870538, 04058509870620, 04058509870583, 04058509870491, 04058509870453, 04058509870514
Basic UDI-DI
4009706Y06309902ZQ
Direct Marketing DI
04058509870507
04058509870477
04058509870552
04058509870460
04058509870484
04058509870521
04058509870668
04058509870576
04058509870637
04058509870606
04058509870644
04058509870675
04058509870569
04058509870446
04058509870590
04058509870545
04058509870613
04058509870651
04058509870538
04058509870620
04058509870583
04058509870491
04058509870453
04058509870514
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

  • Contains Latex

Other properties (12)

  • Sterile: No
  • Implantable: No
  • Reusable: 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