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TENA SmartCare Bladder Sensor Starter Kit

by Novioscan B.V. Netherlands EUDAMED

Ref 10575

EMDN U070299

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number8710499TBSSystRR Basic UDI-DIDate7 Oct 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
10575
Primary DI / UDI-DI
08719327757222
Basic UDI-DI
8710499TBSSystRR
EMDN Code
U070299 External devices for the treatment of incontinence - other
Device Class
Class IIa
Medical Purpose
The TENA SmartCare Bladder Sensor is an on the body ultrasound device for continuous bladder monitoring for support in the prevention of urinary incontinence, in healthcare and homecare environment.

Manufacturer details

EUDAMED SRN
NL-PR-000031738

Other devices from Novioscan B.V.

Properties & raw data

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

Sources (1)

  • EUDAMED 8e12fa8a-aa8c-49a3-892e-82a94b2ef882 61 fields · synced 22 Oct 2026