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by Anita Dr. Helbig GmbH 23 variants

Ref M5-6300

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  • Withdrawn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
M5-6300
Primary DI / UDI-DI
04058509714542, 04058509707315, 04058509714559, 04058509707247, 04058509714368, 04058509714481, 04058509707339, 04058509707254, 04058509714504, 04058509714290, 04058509714313, 04058509714337, 04058509707285, 04058509714375, 04058509714405, 04058509714528, 04058509714535, 04058509714351, 04058509714306, 04058509707278, 04058509714450, 04058509714429, 04058509714283, 04058509714344, 04058509714511, 04058509714443, 04058509714498, 04058509714252, 04058509714320, 04058509707261, 04058509714269, 04058509714474, 04058509714436, 04058509714467, 04058509714412, 04058509707322, 04058509714276, 04058509714399
Basic UDI-DI
4009706Y06309902ZQ
Direct Marketing DI
04058509714542
04058509707315
04058509714559
04058509707247
04058509714368
04058509714481
04058509707339
04058509707254
04058509714504
04058509714290
04058509714313
04058509714337
04058509707285
04058509714375
04058509714405
04058509714528
04058509714535
04058509714351
04058509714306
04058509707278
04058509714450
04058509714429
04058509714283
04058509714344
04058509714511
04058509714443
04058509714498
04058509714252
04058509714320
04058509707261
04058509714269
04058509714474
04058509714436
04058509714467
04058509714412
04058509707322
04058509714276
04058509714399
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