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TeltoHeart

by UAB Teltonika Telemedic Lithuania EUDAMED

Ref TeltoWatch Size L

EMDN Z12039099

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number4779051850TeltoHeartHD Basic UDI-DIDate9 Jul 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Device Name
TeltoHeart
Model / Reference
TeltoWatch Size L
Primary DI / UDI-DI
04779051850198
Basic UDI-DI
4779051850TeltoHeartHD
Direct Marketing DI
04779051850198
EMDN Code
Z12039099 Various instruments to support and monitor vital signs – other
Device Class
Class I
Market of Registration
Lithuania

Manufacturer details

EUDAMED SRN
LT-MF-000007642

Other devices from UAB Teltonika Telemedic

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 04779051850198|4779051850TELTOHEARTHD 61 fields · synced 25 Oct 2026