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Style Teresina

by Anita Dr. Helbig GmbH 4 variants

Ref M7-6372

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  • Withdrawn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
M7-6372
Primary DI / UDI-DI
04058509886652, 04058509886577, 04058509886638, 04058509886669, 04058509886607, 04058509886768, 04058509886683, 04058509886591, 04058509886805, 04058509886720, 04058509886676, 04058509886621, 04058509886782, 04058509886706, 04058509886744, 04058509886751, 04058509886737, 04058509886799, 04058509886713, 04058509886775, 04058509886645, 04058509886584, 04058509886614, 04058509886690
Basic UDI-DI
4009706Y06309902ZQ
Direct Marketing DI
04058509886652
04058509886577
04058509886638
04058509886669
04058509886607
04058509886768
04058509886683
04058509886591
04058509886805
04058509886720
04058509886676
04058509886621
04058509886782
04058509886706
04058509886744
04058509886751
04058509886737
04058509886799
04058509886713
04058509886775
04058509886645
04058509886584
04058509886614
04058509886690
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