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Style Padilla

by Anita Dr. Helbig GmbH 6 variants

Ref M6-6274

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  • Withdrawn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
M6-6274
Primary DI / UDI-DI
04058509828782, 04058509828898, 04058509828805, 04058509828799, 04058509828911, 04058509828850, 04058509828959, 04058509828928, 04058509828904, 04058509828935, 04058509828751, 04058509828966, 04058509828812, 04058509828768, 04058509828942, 04058509828836, 04058509828737, 04058509828867, 04058509828829, 04058509828775, 04058509828744, 04058509828881, 04058509828874, 04058509828843
Basic UDI-DI
4009706Y06309902ZQ
Direct Marketing DI
04058509828782
04058509828898
04058509828805
04058509828799
04058509828911
04058509828850
04058509828959
04058509828928
04058509828904
04058509828935
04058509828751
04058509828966
04058509828812
04058509828768
04058509828942
04058509828836
04058509828737
04058509828867
04058509828829
04058509828775
04058509828744
04058509828881
04058509828874
04058509828843
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