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CardioWatch 287-2-SBL-XL

by Corsano Health BV

Ref CW287-2-SBL-XL

Active European Union

CE MDR

Valid until

15 Nov 2029

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

2 certificates

Certifier Kiwa Assurance B.V.

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number24M00106SUP01 Date21 Oct 2026IssuedStatusActive expires 15 Nov 2029

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • 24M00106CRT02 Active Amended Removed from EUDAMED

    Quality management system EU MDR

    Certifier
    Kiwa Assurance B.V. 1912
    Issued
    2 Apr 2025
    Expires
    15 Nov 2029
    Reason
    Other
  • 24M00106SUP01 Active Supplemented

    Quality management system EU MDR

    Certifier
    Kiwa Assurance B.V. 1912
    Issued
    21 Oct 2026
    Expires
    15 Nov 2029
    Reason
    Other

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
CardioWatch 287-1
Model / Reference
CW287-2-SBL-XL
Primary DI / UDI-DI
08720256776666
Basic UDI-DI
8720256776CW287-1C8
Direct Marketing DI
08720256776666
EMDN Code
Z12040113 Regional plethysmographs
Device Class
Class IIa
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
NL-MF-000013825

Other devices from Corsano Health BV

Properties

  • 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