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Certificates

ISO certificates, EU declarations of conformity, FDA clearance and EUDAMED registrations.
Below are the Corsano regulatory, security, and device certifications, grouped by the entity they apply to. Every PDF links directly to the current signed document.

Corsano Healthcare

ISO 13485 Quality Management System Issued by Kiwa · medical devices QMS View certificate

Kiwa ISO 13485

ISO 27001 Information Security Management Issued by BC Certified · ISO/IEC 21001:2022 standard View certificate

Kiwa ISO 13485

ISO 27017 Information Security Management Issued by BC Certified · NEN-EN-ISO/IEC 27017:2015 standard View certificate

Kiwa ISO 13485

ISO 27018 Software Privacy Management Issued by BC Certified · ISO/IEC 27018:2019 standard View certificate

NEN 7510 Healthcare Information Security (NL) Issued by BC Certified · 2017 standard EN NL

Kiwa ISO 13485

Cyber Essentials Cyber Essentials Plus UK government-backed cyber-security baseline View certificate

HDS:2024 Hébergement de Données de Santé (Health Data Hosting) Issued by BSI EN FR

Kiwa ISO 13485

ACN Agenzia per la Cybersicurezza Nazionale Issued by ACN View certificate

ENS Certificado de conformidad con el ENS Issued by SGS View certificate

Corsano CardioWatch 287-1

Kiwa ISO 13485

CE-MDR EU Conformity Assessment Issued by Kiwa · Notify Body assessment View certificate

DoC EU Declaration of Conformity Signed by Corsano Health BV · REC-73-8 · 2025-07-01 View declaration

Corsano CardioWatch 287-2

Kiwa ISO 13485

CE-MDR EU Conformity Assessment Issued by Kiwa . Notified Body assessment View certificate

DoC EU Declaration of Conformity Signed by Corsano Health BV . 2026-03-18 View declaration

DoC Specification sheet CardioWatch 287-2 v1.2 View document

Security System Security Overview CREC-110-1 . architecture & controls View document

SDS Safety Data Sheet CardioWatch 287-2 . v1.0 View document

MDS2 Manufacturer Disclosure Statement for Medical Device Security Corsano CardioWatch 287-2 System View document

EUDAMED (European Database on Medical Devices)

Kiwa ISO 13485

Manufacturer Corsano Health BV Economic-operator entry on the EU database Open in EUDAMED

Kiwa ISO 13485

Device CardioWatch 287-2 SRN NL-MF-000013825 . currently on the market Open in EUDAMED

FDA (United States)

FDA 510(k) 510(k) clearance – K232548 Corsano page for the FDA clearance record Open page

FDA Premarket 510(k) Premarket Notification FDA AccessData CDRH record Open in FDA.gov

FDA 510(k) 510(k) clearance – K261367 Corsano page for the FDA clearance record Open page

FDA – Establishment Registration & Device Listing

FDA Manufacturer Corsano Health BV Establishment Registration & Device Listing on the US database Open in FDA.gov

FDA Device Corsano Health BV Establishment Registration & Device Listing on the US database Open in FDA.gov

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