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CardioWatch 287-2-SBL

by Corsano Health BV Netherlands EUDAMEDGUDID

Ref CW287-2-SBL Product code MSXEMDN Z12040113

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number08720256776567 UDI-DIDate2 Jun 2026ListedStatusIn distribution
European UnionCE/MDR EUDAMED Number24M00106CRT02 Date2 Apr 2025IssuedStatusActive expires 15 Nov 2029

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 AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • 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-SBL 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-SBL, CardioWatch 287-2-SBL
Primary DI / UDI-DI
08720256776567
Basic UDI-DI
8720256776CW287-1C8
Direct Marketing DI
08720256776567
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
In Commercial Distribution
MRI Safety
MR Unsafe

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
CW287-2-SBL
GUDID
CardioWatch 287-2-SBL
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
  • Lot / Batch Number
  • Serial Number
  • Manufacturing Date
Other properties (19)
  • 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
  • Expiration Date: No

Sources (2)

  • EUDAMED e9b0a834-9a3c-4070-8893-6777cdae285b 61 fields · synced 24 Oct 2026
  • FDA UDI 469f13bd-fe10-4193-ad0b-814bc1f519b6 36 fields · synced 23 Oct 2026