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Penny and Giles Biometrics, Ltd.

United KingdomFDA applicant, unverified

Devices
3

What Penny and Giles Biometrics, Ltd. makes

Penny and Giles Biometrics, Ltd. manufactures ultrasound-guided needle guidance systems, including the BOOST, MICE, and GAMESYS devices for procedural imaging, as well as the MULE and ULE-2 for ultrasound probe positioning and stabilization. The company also produces the MULE-2 and associated hand accessories for enhanced ergonomic use in medical imaging procedures.

The portfolio includes Class I and Class II devices, with submissions recorded under the FDA’s 510(k) clearance pathway. These products are listed in the U.S. regulatory registry, and the company is based in the United States.

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

Catalogue3

Newest first, rows 1-3 of 3

  • Boost, Mice, Gamesys. Ref K924416

    Active Regimes: 510(k) Registry: 510(k) Class:I
  • Mule Ref K934238

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Ule-2, Mule-2, Hand Accessory Kit Ref K962855

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

Frequently asked questions

How many devices does Penny and Giles Biometrics, Ltd. have in the registry?

The registry currently lists 3 devices for Penny and Giles Biometrics, Ltd.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Penny and Giles Biometrics, Ltd.'s devices?

Among its 3 most recently registered devices, Penny and Giles Biometrics, Ltd. has devices listed in FDA 510(k) (3 devices).

What risk classes do Penny and Giles Biometrics, Ltd.'s devices fall under?

Among its 3 most recently registered devices, the classes recorded for Penny and Giles Biometrics, Ltd.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Penny and Giles Biometrics, Ltd. in the registry?

The most recently registered devices listed for Penny and Giles Biometrics, Ltd. include BOOST, MICE, GAMESYS., MULE and ULE-2, MULE-2, HAND ACCESSORY KIT.

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