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TENA SmartCare

by Novioscan B.V. Netherlands EUDAMED

Ref 10565

EMDN U070299

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number8710499SensJU Basic UDI-DIDate22 Oct 2024RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • BE24/00000262 Issued

    Quality management system EU MDR

    Notified body
    Notified body 1639
    Issued
    8 Oct 2024
    Expires
    8 Oct 2029

Specification

EUDAMED · synced 24 Oct 2026

Device Name
TENA SmartCare Bladder Sensor
Model / Reference
10565
Primary DI / UDI-DI
08719326106298
Basic UDI-DI
8710499SensJU
Direct Marketing DI
08719326106298
EMDN Code
U070299 External devices for the treatment of incontinence - other
Device Class
Class IIa
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
NL-MF-000022743

Other devices from Novioscan B.V.

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 (1)

  • EUDAMED 26e89d50-393c-4c4d-a081-d05db4dfabea 61 fields · synced 24 Oct 2026