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by Anita Dr. Helbig GmbH 23 variants

Ref M3-6313

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  • Withdrawn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
M3-6313
Primary DI / UDI-DI
04058509532214, 04058509532221, 04058509532122, 04058509532160, 04058509532290, 04058509532153, 04058509532306, 04058509532238, 04058509532108, 04058509532085, 04058509532177, 04058509532030, 04058509532252, 04058509532115, 04058509531927, 04058509531996, 04058509532054, 04058509531934, 04058509532146, 04058509532009, 04058509531897, 04058509531910, 04058509531903, 04058509532269, 04058509531965, 04058509532184, 04058509532047, 04058509532061, 04058509531989, 04058509532016, 04058509532245, 04058509532276, 04058509531972, 04058509532283, 04058509532092, 04058509532078, 04058509532207, 04058509532023
Basic UDI-DI
4009706Y06309902ZQ
Direct Marketing DI
04058509532214
04058509532221
04058509532122
04058509532160
04058509532290
04058509532153
04058509532306
04058509532238
04058509532108
04058509532085
04058509532177
04058509532030
04058509532252
04058509532115
04058509531927
04058509531996
04058509532054
04058509531934
04058509532146
04058509532009
04058509531897
04058509531910
04058509531903
04058509532269
04058509531965
04058509532184
04058509532047
04058509532061
04058509531989
04058509532016
04058509532245
04058509532276
04058509531972
04058509532283
04058509532092
04058509532078
04058509532207
04058509532023
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

Other properties (13)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: 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