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Harwill Medical (Pty), Ltd.

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Devices
4

What Harwill Medical (Pty), Ltd. makes

Harwill Medical manufactures medical devices including the U-Klip umbilical clamp for neonatal care, the RespAlert for respiratory monitoring, the Whistle Watch for infant apnea detection, and the Cervitula cervical spatula for obstetric examinations.

The company’s portfolio consists of Class II devices, all of which are listed via FDA 510(k) clearance. Harwill Medical is based in the United States.

AI-generated from registry data, 1 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue4

Newest first, rows 1-4 of 4

  • Harwill Medical U-Klip Umbilical Clamp Ref K983204

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Respalert Ref K992618

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Whistle Watch Ref K980550

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Harwill Medical Cervitula Cervical Spatula Ref K983202

    Active Regimes: 510(k) Registry: 510(k) Class:II

Frequently asked questions

How many devices does Harwill Medical (Pty), Ltd. have in the registry?

The registry currently lists 4 devices for Harwill Medical (Pty), Ltd.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Harwill Medical (Pty), Ltd.'s devices?

Among its 4 most recently registered devices, Harwill Medical (Pty), Ltd. has devices listed in FDA 510(k) (4 devices).

What risk classes do Harwill Medical (Pty), Ltd.'s devices fall under?

Among its 4 most recently registered devices, the classes recorded for Harwill Medical (Pty), Ltd.'s devices are Class II. Each device page shows its own class and authorisation.

What are the newest devices from Harwill Medical (Pty), Ltd. in the registry?

The most recently registered devices listed for Harwill Medical (Pty), Ltd. include HARWILL MEDICAL U-KLIP UMBILICAL CLAMP, RESPALERT, WHISTLE WATCH and HARWILL MEDICAL CERVITULA CERVICAL SPATULA.

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