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[SH1] [JW2] of the medical devices listed below.
Zio™ ECG monitors
United States
Zioä monitor ECG monitor
510(k) cleared
Zioä AT monitor ECG monitor
510(k) cleared
Zioä XT monitor ECG monitor
510(k) cleared
Europe & Switzerland
(Currently only available in Austria, Netherlands and Spain)
Zioä 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
Zioä 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
Zioä 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
Zioä ECG Utilization Software (ZEUS)
510(k) cleared
Europe & Switzerland
(Currently only available in Austria, Netherlands and Spain)
Zioä 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
Zioä 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
Zioä 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