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by Anita Dr. Helbig GmbH 23 variants

Ref M4-6330

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  • Withdrawn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
M4-6330
Primary DI / UDI-DI
04058509633751, 04058509633836, 04058509619533, 04058509633959, 04058509633737, 04058509633973, 04058509633720, 04058509633966, 04058509633881, 04058509633683, 04058509633898, 04058509633799, 04058509633690, 04058509619618, 04058509633850, 04058509633997, 04058509633874, 04058509633935, 04058509619526, 04058509633843, 04058509633706, 04058509619564, 04058509633775, 04058509633744, 04058509619595, 04058509619557, 04058509633782, 04058509633911, 04058509619601, 04058509633928, 04058509619588, 04058509633942, 04058509633867, 04058509633829, 04058509633768, 04058509633805, 04058509619571, 04058509633904, 04058509633713, 04058509633980, 04058509619540, 04058509633812
Basic UDI-DI
4009706Y06309902ZQ
Direct Marketing DI
04058509633751
04058509633836
04058509619533
04058509633959
04058509633737
04058509633973
04058509633720
04058509633966
04058509633881
04058509633683
04058509633898
04058509633799
04058509633690
04058509619618
04058509633850
04058509633997
04058509633874
04058509633935
04058509619526
04058509633843
04058509633706
04058509619564
04058509633775
04058509633744
04058509619595
04058509619557
04058509633782
04058509633911
04058509619601
04058509633928
04058509619588
04058509633942
04058509633867
04058509633829
04058509633768
04058509633805
04058509619571
04058509633904
04058509633713
04058509633980
04058509619540
04058509633812
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