Skip to content

Gainor Medical Europe, Ltd.

Country not established

Devices
13

What Gainor Medical Europe, Ltd. makes

Gainor Medical Europe, Ltd. manufactures single-use medical devices for patient care, including safety lancets for blood collection, intravenous priming sets, adhesive bandages, and disposable needles for aspiration and injection. Their portfolio also covers nasal oxygen catheters, blood lancets, hemodialysis blood lines and accessories, gastro-enterostomy tubes, and urine collection bags. Additional offerings include disposable needles for dialysis procedures and hemodialysis system components.

The company’s devices are classified under FDA’s Class I and Class II categories, with relevant products listed via the 510(k) pathway. These products are regulated under US medical device laws, and the manufacturer is based in the United States.

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

Catalogue13

Newest first, rows 1-13 of 13

Search and filter all 13 devices
Skip device list

  • Carelet Safety Lancet Ref K931828

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

  • I.V. Priming Set Ref K913333

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

  • Sureseal Bandage Ref K922441

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

  • Needle, Aspiration & Injection, Disposable Ref K902422

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

  • Cleanlet, Cleanlet Xl & Kids Ref K931827

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

  • Catheter, Nasal, Oxygen Ref K902420

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

  • Surelite And Surelite Xl Blood Lancet Ref K902416

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

  • Hemodialysis Blood Lines Ref K900306

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

  • Stomach, Gastro-Enterostomy Ref K902421

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

  • Bag, Urine Ref K902417

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

  • Needle, Dialysis Ref K902564

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

  • Hemodialysis System And Accessory Ref K902426

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

  • I.V. Administration Set Ref K926448

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

Rows 1-13 of 13

Frequently asked questions

How many devices does Gainor Medical Europe, Ltd. have in the registry?

The registry currently lists 13 devices for Gainor Medical Europe, Ltd.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Gainor Medical Europe, Ltd.'s devices?

Among its 13 most recently registered devices, Gainor Medical Europe, Ltd. has devices listed in FDA 510(k) (13 devices).

What risk classes do Gainor Medical Europe, Ltd.'s devices fall under?

Among its 13 most recently registered devices, the classes recorded for Gainor Medical Europe, Ltd.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Gainor Medical Europe, Ltd. in the registry?

The most recently registered devices listed for Gainor Medical Europe, Ltd. include CARELET SAFETY LANCET, I.V. PRIMING SET, SURESEAL BANDAGE and NEEDLE, ASPIRATION & INJECTION, DISPOSABLE.

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