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by Anita Dr. Helbig GmbH 23 variants

Ref M6-6306

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  • Withdrawn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
M6-6306
Primary DI / UDI-DI
04058509810848, 04058509810732, 04058509811043, 04058509810978, 04058509810671, 04058509810695, 04058509810893, 04058509810855, 04058509810701, 04058509810664, 04058509811067, 04058509811074, 04058509810923, 04058509810961, 04058509810992, 04058509810879, 04058509811036, 04058509810985, 04058509810770, 04058509810831, 04058509810688, 04058509810718, 04058509811012, 04058509810787, 04058509810725, 04058509811050, 04058509810817, 04058509811005, 04058509810947, 04058509810916, 04058509810756, 04058509810824, 04058509810930, 04058509811029, 04058509810909, 04058509810763, 04058509810886, 04058509810749, 04058509810954
Basic UDI-DI
4009706Y06309902ZQ
Direct Marketing DI
04058509810848
04058509810732
04058509811043
04058509810978
04058509810671
04058509810695
04058509810893
04058509810855
04058509810701
04058509810664
04058509811067
04058509811074
04058509810923
04058509810961
04058509810992
04058509810879
04058509811036
04058509810985
04058509810770
04058509810831
04058509810688
04058509810718
04058509811012
04058509810787
04058509810725
04058509811050
04058509810817
04058509811005
04058509810947
04058509810916
04058509810756
04058509810824
04058509810930
04058509811029
04058509810909
04058509810763
04058509810886
04058509810749
04058509810954
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