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by Anita Dr. Helbig GmbH 9 variants

Ref M2-6460

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  • Withdrawn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
M2-6460
Primary DI / UDI-DI
04058509460944, 04058509460913, 04058509461002, 04058509460920, 04058509460999, 04058509460937, 04058509461057, 04058509461088, 04058509460951, 04058509461040, 04058509460968, 04058509461095, 04058509460876, 04058509460883, 04058509461033, 04058509460869, 04058509461071, 04058509460890, 04058509460906, 04058509460975, 04058509461026, 04058509460982, 04058509461019, 04058509461064
Basic UDI-DI
4009706Y06309902ZQ
Direct Marketing DI
04058509460944
04058509460913
04058509461002
04058509460920
04058509460999
04058509460937
04058509461057
04058509461088
04058509460951
04058509461040
04058509460968
04058509461095
04058509460876
04058509460883
04058509461033
04058509460869
04058509461071
04058509460890
04058509460906
04058509460975
04058509461026
04058509460982
04058509461019
04058509461064
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