Regulatory Information
Regulatory information on iRhythm medical devices is described on this website. This information is applicable to references made to Zio-branded medical devices. iRhythm Technologies, Inc., 699 8th Street, Suite 600, San Francisco, CA 94103, U.S.A., is the Legal Manufacturer of the medical devices listed below.
Zio™ ECG monitors
United States
Zio™ monitor ECG monitor
510(k) cleared
Zio™ AT monitor ECG monitor
510(k) cleared
Zio™ XT monitor ECG monitor
510(k) cleared
Europe & Switzerland
(Currently only available in Austria, Netherlands and Spain)
Zio™ monitor ECG monitor
CE marked 2797
EC REP
Emergo Europe
Westervoortsedijk 60
6827 AT Arnhem
The Netherlands
CH REP
MedEnvoy Switzerland
Gotthardstrasse 28
6302 Zug
Switzerland
UK
Zio™ XT monitor ECG monitor
UKCA marked 0086
UKRP
Emergo Consulting (UK) Limited
c/o Cr360 – UL International, Compass House, Vision Park Histon, Cambridge CB24 9BZ
United Kingdom
Japan
Zio™ ECG recording and analysis system
Medical device approval number: 30600BZI00018000
Sales name: Zio ECG recording and analysis system
General name: Long-term electrocardiogram data recorder
DMAH
Micren Healthcare Co., Ltd.
19-1 Harakata-cho, Shinjuku-ku, Tokyo
Software as a Medical Device (SaMD)
United States
Zio™ ECG Utilization Software (ZEUS)
510(k) cleared
Europe & Switzerland
(Currently only available in Austria, Netherlands and Spain)
Zio™ ECG Utilization Software (ZEUS)
CE marked 2797
The conformity mark applies to the following components:
− SFW0073 ECGDL Algorithm
− SFW0037 ZEUS QA Tool
− SFW0030 Clinical Web Service and ZEUS Report
− SFW0075 Clinical Analysis Service
EC REP
Emergo Europe
Westervoortsedijk 60
6827 AT Arnhem
The Netherlands
CH REP
MedEnvoy Switzerland
Gotthardstrasse 28
6302 Zug
Switzerland
UK
Zio™ ECG Utilization Software (ZEUS)
UKCA marked 0086
UKRP
Emergo Consulting (UK) Limited
c/o Cr360 – UL International, Compass House, Vision Park Histon, Cambridge CB24 9BZ
United Kingdom
Japan
Zio™ ECG recording and analysis system
Medical device approval number: 30600BZI00018000
Sales name: Zio ECG recording and analysis system
General name: Long-term electrocardiogram data recorder
DMAH
Micren Healthcare Co., Ltd.
19-1 Harakata-cho, Shinjuku-ku, Tokyo
WEB0231.01