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Rooti Rx

by Rooti Labs Limited. Taiwan EUDAMED

Ref RXAP02-50Model Rooti Rx Patch

EMDN Z12050880

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number471987337RootiRxPatchTH8 Basic UDI-DIDate26 Nov 2023RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Rooti Rx Patch T
Model / Reference
Rooti Rx Patch, RXAP02-50
Primary DI / UDI-DI
04719873370146
Basic UDI-DI
471987337RootiRxPatchTH8
Direct Marketing DI
04719873370146
EMDN Code
Z12050880 Cardiac telemetry instruments - hardware accessories
Device Class
Class I
Market of Registration
Belgium

Manufacturer details

EUDAMED SRN
TW-MF-000004839
Authorised representative
Wellkang Ltd XI-AR-000001836

Other devices from Rooti Labs, Ltd.

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 4d13f7f1-503c-4e2a-b22f-455ff034df8d 61 fields · synced 24 Oct 2026