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Rooti Rx

by Rooti Labs Limited. Taiwan EUDAMED

Ref RXAP02, RXAP03, RXMD01, RXMD02, ASCD01

EMDN Z12050403

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberTW24/00000573 Date7 Nov 2024IssuedStatusActive expires 12 Jul 2029

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • TW24/00000573 Supplemented

    Quality management system EU MDR

    Notified body
    Notified body 1639
    Issued
    7 Nov 2024
    Expires
    12 Jul 2029
    Reason
    Add device or group

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Rooti Rx System
Model / Reference
RXAP02, RXAP03, RXMD01, RXMD02, ASCD01
Primary DI / UDI-DI
04719873370092
Basic UDI-DI
471987337RootiRxDJ
EMDN Code
Z12050403 ECG holter recorders
Device Class
Class IIa
Market of Registration
Belgium

Manufacturer details

EUDAMED SRN
TW-MF-000004839
Authorised representative
Obelis s.a. BE-AR-000000106

Other devices from Rooti Labs, Ltd.

Properties & raw data

Show properties, registry sources and raw records
  • Measuring Function
Other properties (12)
  • 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
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 9d76ffd4-5006-4cf6-9eef-2b21129c538b-1 61 fields · synced 24 Oct 2026