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Point Robotics MedTech, Inc.

TaiwanFDA applicant, unverified FDA

Devices
106
Registrations
FDA
FDA recalls
0

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA establishment

What Point Robotics MedTech, Inc. makes

Point Robotics MedTech, Inc. makes the POINT Kinguide Agile Hybrid Navigation System and related robotic-assisted surgical systems, including versions with DRF accessories and specific model designations such as PSHF01-000, as well as the POINT Kinguide Agile Robotic Arm Surgical Stereotactic System.

These devices 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, 30 Sep 2026. Not verified by deviCERTS or the manufacturer.

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Company details

DUNS number
656383289

FDA establishments1

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

  • Point Robotics Medtech Inc. Xindian Dist. New Taipei · TW FEI 3021976927

Frequently asked questions

How many devices does Point Robotics MedTech, Inc. have in the registry?

The registry currently lists 106 devices for Point Robotics MedTech, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Point Robotics MedTech, Inc.'s devices?

Among its 50 most recently registered devices, Point Robotics MedTech, Inc. has devices listed in FDA GUDID (50 devices).

What risk classes do Point Robotics MedTech, Inc.'s devices fall under?

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

What are the newest devices from Point Robotics MedTech, Inc. in the registry?

The most recently registered devices listed for Point Robotics MedTech, Inc. include POINT ROBOTICS MEDTECH INC. PSHF01-000, POINT ROBOTICS MEDTECH INC. PSHF01-3A1, POINT ROBOTICS MEDTECH INC. PSHF01-2A1 and POINT ROBOTICS MEDTECH INC. PSHF01-3B1.

Which FDA establishments are linked to Point Robotics MedTech, Inc.?

1 FDA establishment is linked to Point Robotics MedTech, Inc. in the registry; they are listed on the company page.

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