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Argosy Intl. (USA), Inc.

United StatesFDA applicant, unverified

Devices
14

What Argosy Intl. (USA), Inc. makes

Argosy International (USA), Inc. manufactures a range of behind-the-ear hearing aids, including models such as the UM VII, 780 UE, and PRIMO CE, as well as customised behind-the-ear devices like the PRIMO CEDM and M25 PP. The company also produces body aids, including the PM 25 PP, and hearing aid attachments designed to attach to eyeglasses, such as the HEARING AID, EYEGLASS and HEARING AID, EYEGLASS, B-12. Additionally, it offers hearing systems like the REXTON and REXTON HS.

These devices are classified under FDA categories Class I and Class II, with regulatory clearance supported by 510(k) submissions. The company is based in the United States and its products are listed under FDA regulatory pathways.

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

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  • Um Vii (Behind The Ear) Ref K780922

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

  • 780 Ue (Behind The Ear) Ref K780916

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

  • Primo Ce (Behind The Ear) Ref K780917

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

  • Mm-Ce Dm (Behind The Ear) Ref K780921

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

  • Pm 25 Pp (Body Aid) Ref K780914

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

  • Hearing Aid, Eyeglass Ref K781094

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

  • Hearing Aid, Eyeglass, B-12 Ref K781096

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

  • Primo Cedm (Behind The Ear) Ref K780918

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

  • M25 Pp (Behind The Ear) Ref K780919

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

  • 780 Se (Behind The Ear) Ref K780915

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

  • Rexton Hs(Hearing System) Ref K791548

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

  • Rexton Ref K823075

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

  • Mm-Ce 11 (Behind The Ear) Ref K780920

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

  • Hearing Aid, Behind The Ear Ref K781095

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

Rows 1-14 of 14

Frequently asked questions

How many devices does Argosy Intl. (Usa), Inc. have in the registry?

The registry currently lists 14 devices for Argosy Intl. (Usa), Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Argosy Intl. (Usa), Inc.'s devices?

Among its 14 most recently registered devices, Argosy Intl. (Usa), Inc. has devices listed in FDA 510(k) (14 devices).

What risk classes do Argosy Intl. (Usa), Inc.'s devices fall under?

Among its 14 most recently registered devices, the classes recorded for Argosy Intl. (Usa), Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Argosy Intl. (Usa), Inc. in the registry?

The most recently registered devices listed for Argosy Intl. (Usa), Inc. include UM VII (BEHIND THE EAR), 780 UE (BEHIND THE EAR), PRIMO CE (BEHIND THE EAR) and MM-CE DM (BEHIND THE EAR).

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