Skip to content

Style Latina Top

by Anita Dr. Helbig GmbH 16 variants

Ref M5-6585-1

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  • Withdrawn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
M5-6585-1
Primary DI / UDI-DI
04058509720826, 04058509717383, 04058509720819, 04058509720840, 04058509720796, 04058509720789, 04058509720864, 04058509720888, 04058509720857, 04058509720871, 04058509717376, 04058509717406, 04058509720802, 04058509717413, 04058509717390, 04058509720895
Basic UDI-DI
4009706Y06309902ZQ
Direct Marketing DI
04058509720826
04058509717383
04058509720819
04058509720840
04058509720796
04058509720789
04058509720864
04058509720888
04058509720857
04058509720871
04058509717376
04058509717406
04058509720802
04058509717413
04058509717390
04058509720895
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