Skip to content

Style Stockholm

by Anita Dr. Helbig GmbH 9 variants

Ref M4-6419

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  • Withdrawn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
M4-6419
Primary DI / UDI-DI
04058509619663, 04058509635342, 04058509635274, 04058509635311, 04058509619632, 04058509635304, 04058509635380, 04058509635403, 04058509635427, 04058509635373, 04058509619670, 04058509619656, 04058509635335, 04058509635328, 04058509635397, 04058509619694, 04058509635359, 04058509635410, 04058509619625, 04058509635366, 04058509619649, 04058509635298
Basic UDI-DI
4009706Y06309902ZQ
Direct Marketing DI
04058509619663
04058509635342
04058509635274
04058509635311
04058509619632
04058509635304
04058509635380
04058509635403
04058509635427
04058509635373
04058509619670
04058509619656
04058509635335
04058509635328
04058509635397
04058509619694
04058509635359
04058509635410
04058509619625
04058509635366
04058509619649
04058509635298
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