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Style Genua

by Anita Dr. Helbig GmbH

Ref M3-6203

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  • Withdrawn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
M3-6203
Primary DI / UDI-DI
04058509533044, 04058509533129, 04058509533112, 04058509533075, 04058509533082, 04058509533136, 04058509533167, 04058509533143, 04058509533174, 04058509533105, 04058509533051, 04058509533068, 04058509533150, 04058509533099, 04058509533020, 04058509533037
Basic UDI-DI
4009706Y06309902ZQ
Direct Marketing DI
04058509533044
04058509533129
04058509533112
04058509533075
04058509533082
04058509533136
04058509533167
04058509533143
04058509533174
04058509533105
04058509533051
04058509533068
04058509533150
04058509533099
04058509533020
04058509533037
EMDN Code
Y063099 Non-extremity prostheses - other
Device Class
Class I
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