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Active

by Anita Dr. Helbig GmbH 3 variants

Ref 1054X

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 Number4009706Y06301801XR Basic UDI-DI Date8 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  • Withdrawn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
Breast prostheses, external
Model / Reference
1054X
Primary DI / UDI-DI
04009706366119, 04009706238591, 04009706238669, 04009706366126, 04009706238638, 04009706238683, 04009706366096, 04009706125419, 04009706123408, 04009706123330, 04009706238706, 04009706123392, 04009706366140, 04009706238645, 04009706366164, 04009706123422, 04009706123439, 04009706123415, 04009706123385, 04009706366102, 04009706123347, 04009706366072, 04009706238621, 04009706238607, 04009706366171, 04009706366157, 04009706366089, 04009706125402, 04009706238584, 04009706366133, 04009706238690
Basic UDI-DI
4009706Y06301801XR
Direct Marketing DI
04009706366119
04009706238591
04009706238669
04009706366126
04009706238638
04009706238683
04009706366096
04009706125419
04009706123408
04009706123330
04009706238706
04009706123392
04009706366140
04009706238645
04009706366164
04009706123422
04009706123439
04009706123415
04009706123385
04009706366102
04009706123347
04009706366072
04009706238621
04009706238607
04009706366171
04009706366157
04009706366089
04009706125402
04009706238584
04009706366133
04009706238690
EMDN Code
Y063018 External breast prostheses
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

Other properties (13)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: 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