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P.T. Setio Harto, Ltd.

Country not established

Devices
1

What P.T. Setio Harto, Ltd. makes

P.T. Setio Harto, Ltd. manufactures SKIFA, a plastic disposable syringe designed for single-use medical applications.

The company’s products are regulated as Class II devices under FDA 510(k) clearance requirements and are listed in the FDA’s 510(k) database. The manufacturer is based in the United States.

AI-generated from registry data, 2 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue1

Newest first, rows 1-1 of 1

Frequently asked questions

How many devices does P.T. Setio Harto, Ltd. have in the registry?

The registry currently lists 1 device for P.T. Setio Harto, Ltd.. Devices recorded under merged duplicate company entries are counted once.

Which registries list P.T. Setio Harto, Ltd.'s devices?

Among its 1 most recently registered device, P.T. Setio Harto, Ltd. has devices listed in FDA 510(k) (1 device).

What risk classes do P.T. Setio Harto, Ltd.'s devices fall under?

Among its 1 most recently registered device, the classes recorded for P.T. Setio Harto, Ltd.'s devices are Class II. Each device page shows its own class and authorisation.

What are the newest devices from P.T. Setio Harto, Ltd. in the registry?

The most recently registered devices listed for P.T. Setio Harto, Ltd. include SKIFA, PLASTIC DISPOSABLE SYRINGE.

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