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by Anita Dr. Helbig GmbH 3 variants

Ref M7-6552-1

Active European Union

CE MDR

Valid until

No date given

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  • Withdrawn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
M7-6552-1
Primary DI / UDI-DI
04058509886935, 04058509886980, 04058509886843, 04058509886812, 04058509886942, 04058509886836, 04058509886973, 04058509886959, 04058509886881, 04058509886911, 04058509886904, 04058509886850, 04058509886874, 04058509886966, 04058509886829, 04058509886898, 04058509886928, 04058509886867
Basic UDI-DI
4009706Y06309902ZQ
Direct marketing DI
04058509886935
04058509886980
04058509886843
04058509886812
04058509886942
04058509886836
04058509886973
04058509886959
04058509886881
04058509886911
04058509886904
04058509886850
04058509886874
04058509886966
04058509886829
04058509886898
04058509886928
04058509886867
EMDN code
Y063099 Non-extremity prostheses - other
Device class
Class I
EU registration type
Standard device
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 (13)

  • Supplied sterile: No
  • Sterilise before use: No
  • Implantable: No
  • Reusable: No
  • Reprocessed single-use device: No
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No
  • Incorporates a substance derived from human blood or plasma: No
  • Contains human tissues or cells: No
  • Contains animal tissues or cells: No
  • Contains endocrine-disrupting substances: No
  • Administering medicine: No
  • Measuring function: No
  • Incorporates a medicinal substance: No