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by Anita Dr. Helbig GmbH 23 variants

Ref M2-6366

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  • Withdrawn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
M2-6366
Primary DI / UDI-DI
04058509472978, 04058509472886, 04058509472855, 04058509473197, 04058509472848, 04058509473173, 04058509473029, 04058509473180, 04058509473135, 04058509472787, 04058509473043, 04058509473067, 04058509472930, 04058509472923, 04058509472862, 04058509472794, 04058509473166, 04058509472985, 04058509473104, 04058509472954, 04058509473050, 04058509472893, 04058509473111, 04058509472916, 04058509472961, 04058509473036, 04058509472992, 04058509472947, 04058509473142, 04058509473081, 04058509472879, 04058509473074, 04058509472831, 04058509472817, 04058509473128, 04058509472909, 04058509473159, 04058509473098, 04058509473012, 04058509472824, 04058509473005, 04058509472800
Basic UDI-DI
4009706Y06309902ZQ
Direct Marketing DI
04058509472978
04058509472886
04058509472855
04058509473197
04058509472848
04058509473173
04058509473029
04058509473180
04058509473135
04058509472787
04058509473043
04058509473067
04058509472930
04058509472923
04058509472862
04058509472794
04058509473166
04058509472985
04058509473104
04058509472954
04058509473050
04058509472893
04058509473111
04058509472916
04058509472961
04058509473036
04058509472992
04058509472947
04058509473142
04058509473081
04058509472879
04058509473074
04058509472831
04058509472817
04058509473128
04058509472909
04058509473159
04058509473098
04058509473012
04058509472824
04058509473005
04058509472800
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