Skip to content

Style Stockholm

by Anita Dr. Helbig GmbH 9 variants

Ref M6-6301

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  • Withdrawn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
M6-6301
Primary DI / UDI-DI
04058509804441, 04058509804403, 04058509804540, 04058509804489, 04058509804373, 04058509804564, 04058509804380, 04058509804359, 04058509804496, 04058509804526, 04058509804557, 04058509804533, 04058509804472, 04058509804571, 04058509804366, 04058509804410, 04058509804465, 04058509804397, 04058509804502, 04058509804458, 04058509804427, 04058509804519
Basic UDI-DI
4009706Y06309902ZQ
Direct Marketing DI
04058509804441
04058509804403
04058509804540
04058509804489
04058509804373
04058509804564
04058509804380
04058509804359
04058509804496
04058509804526
04058509804557
04058509804533
04058509804472
04058509804571
04058509804366
04058509804410
04058509804465
04058509804397
04058509804502
04058509804458
04058509804427
04058509804519
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