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Zoe Medical, Inc.

United StatesFDA 510(k) applicant, unverified FDA FEI 3003294644

Devices
50
Registrations
FDA
FDA recalls
0

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA FEI

What Zoe Medical, Inc. makes

Zoe Medical, Inc. manufactures patient monitoring systems and medical devices, including the Well@Home system, the Ultraview DM3 monitor, the 740 SafeSAT, and the Nightingale monitoring system.

These products are classified as Class II medical devices and are listed in the FDA 510(k) registry. The company is based in the United States.

AI-generated from registry data, 4 Oct 2026. Not verified by deviCERTS or the manufacturer.

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Company details

FDA FEI number
3003294644
Address
460 BOSTON ST., TOPSFIELD, MA, 01983

Frequently asked questions

How many devices does Zoe Medical, Inc. have in the registry?

The registry currently lists 50 devices for Zoe Medical, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Zoe Medical, Inc.'s devices?

Among its 50 most recently registered devices, Zoe Medical, Inc. has devices listed in FDA 510(k) (5 devices) and FDA GUDID (45 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do Zoe Medical, Inc.'s devices fall under?

Among its 50 most recently registered devices, the classes recorded for Zoe Medical, Inc.'s devices are Class II. Each device page shows its own class and authorisation.

What are the newest devices from Zoe Medical, Inc. in the registry?

The most recently registered devices listed for Zoe Medical, Inc. include Ultraview DM3 91330-N, 740 SELECT 740 SELECT-XMF0W, NA ECG Intermediate Cable and NA ECG Lead, 1 meter.

Generated automatically from registry data and not verified by a human reviewer.