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Rossmax International, Ltd.

TaiwanFDA applicant, unverified FDA

Devices
16
Registrations
FDA
FDA recalls
0

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA establishment

What Rossmax International, Ltd. makes

Rossmax International, Ltd. manufactures non-invasive automatic blood pressure monitors, including wristwatch-style devices and upper-arm models. Their portfolio includes standalone wrist monitors (e.g., RM-4100, V46, BPW138) and hybrid designs with additional health metrics (e.g., CardioCare 1000I). Tabletop and portable models (e.g., Medipro 10/60, S380) are also part of their offerings, targeting home and clinical use.

The company’s devices fall under Class II regulatory classification in the U.S. and are listed in the FDA 510(k) database as authorised under the U.S. Food and Drug Administration. Their headquarters are based in the United States.

AI-generated from registry data, 3 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue16

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FDA establishments1

Registered with the FDA under this company group, matched by name.

  • Rossmax International Ltd. TAIPEI · TW FEI 3003247551

Frequently asked questions

How many devices does Rossmax International, Ltd. have in the registry?

The registry currently lists 16 devices for Rossmax International, Ltd.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Rossmax International, Ltd.'s devices?

Among its 16 most recently registered devices, Rossmax International, Ltd. has devices listed in FDA 510(k) (16 devices).

What risk classes do Rossmax International, Ltd.'s devices fall under?

Among its 16 most recently registered devices, the classes recorded for Rossmax International, Ltd.'s devices are Class II. Each device page shows its own class and authorisation.

What are the newest devices from Rossmax International, Ltd. in the registry?

The most recently registered devices listed for Rossmax International, Ltd. include ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL RM-4100, ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL V46, ROSSMAX NON-INVASIVE BLOOD PRESSURE MONITORS, MODELS S380, K350 and ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL BPW138.

Which FDA establishments are linked to Rossmax International, Ltd.?

1 FDA establishment is linked to Rossmax International, Ltd. in the registry; they are listed on the company page.

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