Skip to content

Style Dirban

by Anita Dr. Helbig GmbH 23 variants

Ref M7-6388

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  • Withdrawn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
M7-6388
Primary DI / UDI-DI
04058509895838, 04058509896149, 04058509896248, 04058509896378, 04058509896217, 04058509896132, 04058509896187, 04058509896323, 04058509896385, 04058509895845, 04058509896392, 04058509896347, 04058509896156, 04058509896163, 04058509896330, 04058509896231, 04058509896125, 04058509896279, 04058509896309, 04058509896354, 04058509895814, 04058509896224, 04058509895852, 04058509896361, 04058509895876, 04058509896194, 04058509896255, 04058509896262, 04058509895869, 04058509896200, 04058509896286, 04058509896316, 04058509895821, 04058509895807, 04058509896293, 04058509896170
Basic UDI-DI
4009706Y06309902ZQ
Direct Marketing DI
04058509895838
04058509896149
04058509896248
04058509896378
04058509896217
04058509896132
04058509896187
04058509896323
04058509896385
04058509895845
04058509896392
04058509896347
04058509896156
04058509896163
04058509896330
04058509896231
04058509896125
04058509896279
04058509896309
04058509896354
04058509895814
04058509896224
04058509895852
04058509896361
04058509895876
04058509896194
04058509896255
04058509896262
04058509895869
04058509896200
04058509896286
04058509896316
04058509895821
04058509895807
04058509896293
04058509896170
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