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by Anita Dr. Helbig GmbH 23 variants

Ref M3-6339

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  • Withdrawn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
M3-6339
Primary DI / UDI-DI
04058509545320, 04058509545337, 04058509545474, 04058509545528, 04058509545610, 04058509545641, 04058509545634, 04058509545306, 04058509545498, 04058509545368, 04058509545351, 04058509545511, 04058509545542, 04058509545580, 04058509545290, 04058509545382, 04058509545399, 04058509545344, 04058509545481, 04058509545375, 04058509545283, 04058509545559, 04058509545665, 04058509545603, 04058509545597, 04058509545566, 04058509545658, 04058509545412, 04058509545450, 04058509545436, 04058509545689, 04058509545573, 04058509545696, 04058509545672, 04058509545429, 04058509545443, 04058509545504, 04058509545405, 04058509545313, 04058509545627
Basic UDI-DI
4009706Y06309902ZQ
Direct Marketing DI
04058509545320
04058509545337
04058509545474
04058509545528
04058509545610
04058509545641
04058509545634
04058509545306
04058509545498
04058509545368
04058509545351
04058509545511
04058509545542
04058509545580
04058509545290
04058509545382
04058509545399
04058509545344
04058509545481
04058509545375
04058509545283
04058509545559
04058509545665
04058509545603
04058509545597
04058509545566
04058509545658
04058509545412
04058509545450
04058509545436
04058509545689
04058509545573
04058509545696
04058509545672
04058509545429
04058509545443
04058509545504
04058509545405
04058509545313
04058509545627
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