Skip to content

Style Tavira

by Anita Dr. Helbig GmbH 9 variants

Ref M7-6216

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  • Withdrawn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
M7-6216
Primary DI / UDI-DI
04058509872334, 04058509871535, 04058509872327, 04058509872211, 04058509872273, 04058509872242, 04058509872303, 04058509871573, 04058509872297, 04058509871559, 04058509872396, 04058509872389, 04058509871542, 04058509872365, 04058509872198, 04058509872228, 04058509872266, 04058509872402, 04058509872358, 04058509872259, 04058509872174, 04058509872181, 04058509872341, 04058509872372, 04058509872310, 04058509872235, 04058509872280, 04058509871528, 04058509871566, 04058509872204
Basic UDI-DI
4009706Y06309902ZQ
Direct Marketing DI
04058509872334
04058509871535
04058509872327
04058509872211
04058509872273
04058509872242
04058509872303
04058509871573
04058509872297
04058509871559
04058509872396
04058509872389
04058509871542
04058509872365
04058509872198
04058509872228
04058509872266
04058509872402
04058509872358
04058509872259
04058509872174
04058509872181
04058509872341
04058509872372
04058509872310
04058509872235
04058509872280
04058509871528
04058509871566
04058509872204
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