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by Anita Dr. Helbig GmbH 3 variants

Ref M5-6555-1

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  • Withdrawn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
M5-6555-1
Primary DI / UDI-DI
04058509707445, 04058509707469, 04058509716003, 04058509707483, 04058509715983, 04058509716096, 04058509716034, 04058509707476, 04058509716010, 04058509716027, 04058509715990, 04058509707452, 04058509707438, 04058509716041, 04058509716072, 04058509716089, 04058509716058, 04058509716065
Basic UDI-DI
4009706Y06309902ZQ
Direct marketing DI
04058509707445
04058509707469
04058509716003
04058509707483
04058509715983
04058509716096
04058509716034
04058509707476
04058509716010
04058509716027
04058509715990
04058509707452
04058509707438
04058509716041
04058509716072
04058509716089
04058509716058
04058509716065
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