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Style Padilla

by Anita Dr. Helbig GmbH 6 variants

Ref M4-6200

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  • Withdrawn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
M4-6200
Primary DI / UDI-DI
04058509633454, 04058509612381, 04058509633508, 04058509633522, 04058509612398, 04058509633423, 04058509612404, 04058509633409, 04058509633553, 04058509633393, 04058509633447, 04058509633492, 04058509633539, 04058509633416, 04058509633515, 04058509633485, 04058509633430, 04058509612374, 04058509633546, 04058509612367, 04058509633386, 04058509633461
Basic UDI-DI
4009706Y06309902ZQ
Direct Marketing DI
04058509633454
04058509612381
04058509633508
04058509633522
04058509612398
04058509633423
04058509612404
04058509633409
04058509633553
04058509633393
04058509633447
04058509633492
04058509633539
04058509633416
04058509633515
04058509633485
04058509633430
04058509612374
04058509633546
04058509612367
04058509633386
04058509633461
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