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Style Padilla

by Anita Dr. Helbig GmbH 6 variants

Ref M5-6240

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  • Withdrawn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
M5-6240
Primary DI / UDI-DI
04058509735714, 04058509735608, 04058509721724, 04058509735677, 04058509735646, 04058509721748, 04058509735684, 04058509721731, 04058509735615, 04058509735660, 04058509721779, 04058509735738, 04058509721755, 04058509735691, 04058509721762, 04058509735592, 04058509735585, 04058509735752, 04058509735721, 04058509735653, 04058509735639, 04058509735707, 04058509735745, 04058509735622
Basic UDI-DI
4009706Y06309902ZQ
Direct Marketing DI
04058509735714
04058509735608
04058509721724
04058509735677
04058509735646
04058509721748
04058509735684
04058509721731
04058509735615
04058509735660
04058509721779
04058509735738
04058509721755
04058509735691
04058509721762
04058509735592
04058509735585
04058509735752
04058509735721
04058509735653
04058509735639
04058509735707
04058509735745
04058509735622
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