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TriCup

by Anita Dr. Helbig GmbH Germany EUDAMED

Ref 1089X

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
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Breast prostheses, external
Model / Reference
1089X
Primary DI / UDI-DI
04009706561842, 04009706561811, 04009706561873, 04009706561880, 04009706561835
Basic UDI-DI
4009706Y06301801XR
Direct Marketing DI
04009706561842
04009706561811
04009706561873
04009706561880
04009706561835
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 (5)

  • EUDAMED 5b195400-db5b-4cbe-b860-a54f857f6349 61 fields · synced 22 Oct 2026
  • EUDAMED 04009706561811|4009706Y06301801XR 61 fields · synced 18 Jul 2026
  • EUDAMED 04009706561873|4009706Y06301801XR 61 fields · synced 29 Jul 2026
  • EUDAMED 04009706561880|4009706Y06301801XR 61 fields · synced 2 Aug 2026
  • EUDAMED 04009706561835|4009706Y06301801XR 61 fields · synced 5 Oct 2026