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Hydron Pty Limited

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Devices
1

What Hydron Pty Limited makes

Hydron Pty Limited manufactures the ALPHASPHERE ORBITAL IMPLANT, a medical device designed for orbital implantation.

The ALPHASPHERE ORBITAL IMPLANT is classified as a Class II device under FDA regulations and is listed in the FDA’s 510(k) registry. The company is based in the United States.

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

Catalogue1

Newest first, rows 1-1 of 1

  • Alphasphere Orbital Implant Ref K053298

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

Frequently asked questions

How many devices does Hydron Pty Limited have in the registry?

The registry currently lists 1 device for Hydron Pty Limited. Devices recorded under merged duplicate company entries are counted once.

Which registries list Hydron Pty Limited's devices?

Among its 1 most recently registered device, Hydron Pty Limited has devices listed in FDA 510(k) (1 device).

What risk classes do Hydron Pty Limited's devices fall under?

Among its 1 most recently registered device, the classes recorded for Hydron Pty Limited's devices are Class II. Each device page shows its own class and authorisation.

What are the newest devices from Hydron Pty Limited in the registry?

The most recently registered devices listed for Hydron Pty Limited include ALPHASPHERE ORBITAL IMPLANT.

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