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T1 SmarterSkin Plus Sensor

by Umana Medical Technologies Ltd EUDAMED

Active European Union

Ref T1SPModel T1S

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number53506279T1SMARTERSKIN37 Basic UDI-DIDate7 Nov 2024RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
T1 SmarterSkin Sensor
Model / Reference
T1S, T1SP
Primary DI / UDI-DI
05350627900272
Basic UDI-DI
53506279T1SMARTERSKIN37
EMDN Code
Z12050385 Electrocardiographs - consumables
Device Class
Class I
Market of Registration
Türkiye

Manufacturer details

EUDAMED SRN
MT-MF-000018092

Related devices

Category: Electrocardiographic lead set, reusable

Other devices from Umana Medical Technologies Ltd

Properties

Show properties
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