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ATOMS Tunneller

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

Ref ATS5010

EMDN U0780

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number++EAMIA5B9C1D1LY 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

Model / Reference
ATS5010
Primary DI / UDI-DI
+EAMIATS50100
Basic UDI-DI
++EAMIA5B9C1D1LY
Direct Marketing DI
+EAMIATS50100
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

Other devices from A.M.I. Agency for Medical Innovations GmbH

See all devices from A.M.I. Agency for Medical Innovations GmbH →

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 4e19a111-d04b-49a4-a29d-d6c5eebf1e90 61 fields · synced 22 Oct 2026