Skip to content

Style Tavira

by Anita Dr. Helbig GmbH 9 variants

Ref M5-6281

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  • Withdrawn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
M5-6281
Primary DI / UDI-DI
04058509740107, 04058509740138, 04058509740268, 04058509710452, 04058509714818, 04058509714894, 04058509714832, 04058509710469, 04058509740190, 04058509710483, 04058509714801, 04058509740145, 04058509740237, 04058509714825, 04058509710490, 04058509740251, 04058509740244, 04058509714856, 04058509714849, 04058509714887, 04058509740183, 04058509710506, 04058509714795, 04058509740176, 04058509740213, 04058509740114, 04058509740152, 04058509710476, 04058509740206, 04058509714870, 04058509740121, 04058509740091, 04058509740220, 04058509714863, 04058509714788, 04058509740169
Basic UDI-DI
4009706Y06309902ZQ
Direct Marketing DI
04058509740107
04058509740138
04058509740268
04058509710452
04058509714818
04058509714894
04058509714832
04058509710469
04058509740190
04058509710483
04058509714801
04058509740145
04058509740237
04058509714825
04058509710490
04058509740251
04058509740244
04058509714856
04058509714849
04058509714887
04058509740183
04058509710506
04058509714795
04058509740176
04058509740213
04058509740114
04058509740152
04058509710476
04058509740206
04058509714870
04058509740121
04058509740091
04058509740220
04058509714863
04058509714788
04058509740169
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