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A.M.I. TVA Tunneller

by A.M.I. Agency for Medical Innovations GmbH United States EUDAMED

Ref TVA5030

EMDN U0780

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number++EAMIA6B9C1D1MH Basic UDI-DIDate29 Aug 2025RegisteredStatusActive

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
Tunnellers
Model / Reference
TVA5030
Primary DI / UDI-DI
+EAMITVA50300
Basic UDI-DI
++EAMIA6B9C1D1MH
Direct Marketing DI
+EAMITVA50300
EMDN Code
U0780 Devices for the treatment of incontinence - accessories
Device Class
Class I
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
AT-MF-000016792

Properties & raw data

Show properties, registry sources and raw records
  • Reusable
Other properties (12)
  • Sterile: No
  • Implantable: 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 (1)

  • EUDAMED f4345e24-c878-4f3c-b397-bb64117f1a3c 61 fields · synced 22 Oct 2026