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Style Tavira

by Anita Dr. Helbig GmbH 9 variants

Ref M7-6228

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  • Withdrawn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
M7-6228
Primary DI / UDI-DI
04058509895791, 04058509896613, 04058509896491, 04058509896460, 04058509896576, 04058509896552, 04058509896521, 04058509896569, 04058509896620, 04058509896606, 04058509896415, 04058509896484, 04058509896453, 04058509895746, 04058509896583, 04058509896507, 04058509895760, 04058509895784, 04058509895777, 04058509896446, 04058509896439, 04058509896545, 04058509896590, 04058509896422
Basic UDI-DI
4009706Y06309902ZQ
Direct Marketing DI
04058509895791
04058509896613
04058509896491
04058509896460
04058509896576
04058509896552
04058509896521
04058509896569
04058509896620
04058509896606
04058509896415
04058509896484
04058509896453
04058509895746
04058509896583
04058509896507
04058509895760
04058509895784
04058509895777
04058509896446
04058509896439
04058509896545
04058509896590
04058509896422
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