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CardioWatch 287-2

by Corsano Health BV Netherlands EUDAMEDGUDID

Ref CW287-2

Product code MSXEMDN Z12040113

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number24M00106CRT02 Date2 Apr 2025IssuedStatusActive expires 15 Nov 2029
United StatesGUDID listing GUDID Number08720256776529 UDI-DIDate19 Jun 2024ListedStatusListed

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Recalls: none on record (FDA, checked 24 Oct 2026)

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 24M00106CRT02 Amended

    Quality management system EU MDR

    Notified body
    Notified body 1912
    Issued
    2 Apr 2025
    Expires
    15 Nov 2029
    Reason
    Other

Specification

EUDAMED · GUDID · synced 24 Oct 2026

Trade Name
CardioWatch 287-2 EUDAMED
Corsano CardioWatch 287-2 System GUDID
Generic Name
Wearable multiple physiological parameter recorder, reusable
Device Name
CardioWatch 287-1
Model / Ref / Catalog
CW287-2, CardioWatch 287-2
Primary DI / UDI-DI
08720256776529, 08720256776550
Basic UDI-DI
8720256776CW287-1C8
Direct Marketing DI
08720256776529
08720256776550
510(k) Number
FDA Product Code
MSX, DQA, BZG, BZQ, FLL, DRG, DXN, FRI
EMDN Code
Z12040113 Regional plethysmographs
GMDN Term
Wearable multiple physiological parameter recorder, reusable
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
870.2300, 870.2700, 868.1840, 868.2375, 880.2910, 870.2910, 870.1130, 880.2700
Market of Registration
Netherlands
Commercial Distribution
Not in Commercial Distribution
In Commercial Distribution
MRI Safety
MR Unsafe

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
CW287-2
GUDID
CardioWatch 287-2
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
NL-MF-000013825

Other devices from Corsano Health BV

Properties & raw data

Show properties, registry sources and raw records
  • Measuring Function
  • Prescription Use
  • Serial Number
  • Manufacturing Date
Other properties (20)
  • Sterile: No
  • Single Use: 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No

Sources (4)

  • EUDAMED 56bea1f3-4834-46fb-ae31-56a897c32b4d 61 fields · synced 22 Oct 2026
  • FDA UDI 52c58cd8-aa80-4846-9599-0dcdde57cd95 36 fields · synced 30 May 2026
  • FDA UDI f93083f2-587b-401c-a105-2f574757863d 35 fields · synced 23 Oct 2026
  • EUDAMED 08720256776550|8720256776CW287-1C8 61 fields · synced 24 Oct 2026