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Style Teresina

by Anita Dr. Helbig GmbH 4 variants

Ref M5-6303

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  • Withdrawn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
M5-6303
Primary DI / UDI-DI
04058509736216, 04058509736193, 04058509736124, 04058509736179, 04058509730528, 04058509730504, 04058509730559, 04058509736117, 04058509730535, 04058509730498, 04058509736148, 04058509736186, 04058509736209, 04058509736131, 04058509736162, 04058509736155, 04058509736100, 04058509736070, 04058509736094, 04058509730481, 04058509730511, 04058509736087, 04058509730542, 04058509736063
Basic UDI-DI
4009706Y06309902ZQ
Direct Marketing DI
04058509736216
04058509736193
04058509736124
04058509736179
04058509730528
04058509730504
04058509730559
04058509736117
04058509730535
04058509730498
04058509736148
04058509736186
04058509736209
04058509736131
04058509736162
04058509736155
04058509736100
04058509736070
04058509736094
04058509730481
04058509730511
04058509736087
04058509730542
04058509736063
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