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Fashion

by Anita Dr. Helbig GmbH Germany EUDAMED

Ref 1152X EMDN Y063018

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number4009706Y06301801XR Basic UDI-DIDate8 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Breast prostheses, external
Model / Reference
1152X
Primary DI / UDI-DI
04009706357803, 04009706357841, 04009706357858, 04009706357797, 04009706357834, 04009706357865
Basic UDI-DI
4009706Y06301801XR
Direct Marketing DI
04009706357803
04009706357841
04009706357858
04009706357797
04009706357834
04009706357865
EMDN Code
Y063018 External breast prostheses
Device Class
Class I
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 & raw data

Show properties, registry sources and raw records
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

Sources (6)

  • EUDAMED 1be9ab78-2659-4989-9543-a107672e2c0b 61 fields · synced 24 Oct 2026
  • EUDAMED 04009706357841|4009706Y06301801XR 61 fields · synced 10 Jul 2026
  • EUDAMED 04009706357858|4009706Y06301801XR 61 fields · synced 18 Jul 2026
  • EUDAMED 04009706357797|4009706Y06301801XR 61 fields · synced 19 Jul 2026
  • EUDAMED 04009706357834|4009706Y06301801XR 61 fields · synced 21 Jul 2026
  • EUDAMED 04009706357865|4009706Y06301801XR 61 fields · synced 5 Oct 2026