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by Anita Dr. Helbig GmbH 9 variants

Ref M7-6311

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  • Withdrawn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
M7-6311
Primary DI / UDI-DI
04058509870781, 04058509870699, 04058509870842, 04058509870910, 04058509870712, 04058509870903, 04058509870866, 04058509870774, 04058509870750, 04058509870897, 04058509870682, 04058509870811, 04058509870859, 04058509870767, 04058509870705, 04058509870743, 04058509870729, 04058509870798, 04058509870835, 04058509870873, 04058509870804, 04058509870880, 04058509870736, 04058509870828
Basic UDI-DI
4009706Y06309902ZQ
Direct Marketing DI
04058509870781
04058509870699
04058509870842
04058509870910
04058509870712
04058509870903
04058509870866
04058509870774
04058509870750
04058509870897
04058509870682
04058509870811
04058509870859
04058509870767
04058509870705
04058509870743
04058509870729
04058509870798
04058509870835
04058509870873
04058509870804
04058509870880
04058509870736
04058509870828
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