Certifications, Patents, and Trademarks


Diagnosys LLC is an ISO 13485:2016 / MDSAP certified corporation with FDA-registered medical device establishment. Diagnosys’ systems are CE marked and FDA 510(k) cleared and also has products installed worldwide with country specific medical device approvals where required. All Diagnosys systems are RoHS compliant as well as ETL marked.

MDSAP Certificate

Diagnosys LLC has been registered by Intertek, an MDSAP recognized auditing organization, as conforming to the requirements of:

ISO 13485:2016

Australia: Therapeutic Goods (Medical Devices) Regulations, 2002, Schedule 3 Part 1 (excluding Part 1.6)

Canada: Medical Devices Regulations – Part 1- SOR 98/282

United States: 21 CFR 820, 21 CFR 803, 21 CFR 806, 21 CFR 807 (Subparts A to D)

Japan: MHLW Ministerial Ordinance 169, Article 4 to Article 68; PMD Act

Diagnosys MDSAP Certificate

EC Certificate

Diagnosys LLC’s full quality assurance system has been certified by Intertek SEMKO AB (0143), a Notified Body according to Directive 93/42/EEC on medical devices. Conforming to Directive 93/42/EEC on Medical Devices, Annex II excluding (4) entitles Diagnosys LLC to use the CE Mark on our electrophysiology equipment.


US 10,820,824

US 11,357,442

US 11,497,911

US 10,893,823

JP 6,796,642


ColorDome: 88059275

Celeris: 88059184

Espion: 88059226

DiagnosysFST: 88912071