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by Anita Dr. Helbig GmbH 23 variants

Ref M4-6317

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  • Withdrawn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
M4-6317
Primary DI / UDI-DI
04058509638718, 04058509640322, 04058509638701, 04058509640315, 04058509640292, 04058509640247, 04058509638671, 04058509640223, 04058509640261, 04058509638695, 04058509638725, 04058509640339, 04058509640254, 04058509638688, 04058509640285, 04058509640278, 04058509640308, 04058509640230
Basic UDI-DI
4009706Y06309902ZQ
Direct Marketing DI
04058509638718
04058509640322
04058509638701
04058509640315
04058509640292
04058509640247
04058509638671
04058509640223
04058509640261
04058509638695
04058509638725
04058509640339
04058509640254
04058509638688
04058509640285
04058509640278
04058509640308
04058509640230
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