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by Anita Dr. Helbig GmbH 23 variants

Ref M6-6318

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  • Withdrawn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
M6-6318
Primary DI / UDI-DI
04058509818516, 04058509818684, 04058509818639, 04058509818448, 04058509818592, 04058509818653, 04058509818738, 04058509818561, 04058509818554, 04058509818363, 04058509818769, 04058509818431, 04058509818721, 04058509818707, 04058509818578, 04058509818462, 04058509818752, 04058509818677, 04058509818417, 04058509818455, 04058509818486, 04058509818509, 04058509818400, 04058509818424, 04058509818530, 04058509818622, 04058509818387, 04058509818691, 04058509818370, 04058509818547, 04058509818714, 04058509818660, 04058509818745, 04058509818646, 04058509818479, 04058509818608, 04058509818394, 04058509818493, 04058509818523, 04058509818356
Basic UDI-DI
4009706Y06309902ZQ
Direct Marketing DI
04058509818516
04058509818684
04058509818639
04058509818448
04058509818592
04058509818653
04058509818738
04058509818561
04058509818554
04058509818363
04058509818769
04058509818431
04058509818721
04058509818707
04058509818578
04058509818462
04058509818752
04058509818677
04058509818417
04058509818455
04058509818486
04058509818509
04058509818400
04058509818424
04058509818530
04058509818622
04058509818387
04058509818691
04058509818370
04058509818547
04058509818714
04058509818660
04058509818745
04058509818646
04058509818479
04058509818608
04058509818394
04058509818493
04058509818523
04058509818356
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