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Noah Labs Ark

by Noah Labs GmbH EUDAMED

Active European Union

Ref 2.x.xModel Noah Labs Telemonitoring

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberZ-23-011-S-IX-N2 Date27 May 2026IssuedStatusActive expires 12 Mar 2029

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • Z-23-011-S-IX-N2 Active Amended

    Quality management system EU MDR

    Notified body
    0633
    Issued
    27 May 2026
    Expires
    12 Mar 2029
    Reason
    Other

Specification

EUDAMED

Device Name
Noah Labs Telemonitoring
Model / Reference
Noah Labs Telemonitoring, 2.x.x
Primary DI / UDI-DI
04262404180009
Basic UDI-DI
426240418ME
Direct Marketing DI
04262404180009
EMDN Code
Z12030292 Vital signs monitoring instruments - medical device software
Device Class
Class IIa
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000030840

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