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Orange Medical Instruments, Inc.

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Devices
12

What Orange Medical Instruments, Inc. makes

Orange Medical Instruments, Inc. manufactures insulin delivery and monitoring devices, including U100 insulin syringes (both standard and click-count), disposable micro-infusion systems, and programmable infusion pumps for insulin administration. The company also produces lancets, reagent strips, and control solutions for blood glucose monitoring, as well as catheters with protective coatings for medical procedures.

The portfolio includes Class I and Class II devices, with regulatory submissions recorded in the FDA’s 510(k) clearance registry. Products are listed under U.S. jurisdiction, adhering to FDA requirements for medical devices. The manufacturer operates from the United States.

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

Catalogue12

Newest first, rows 1-12 of 12

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  • Micro-Beta U100 Syringe Ref K844796

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Continucath Ref K860808

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Disposable Micro-Infusion System Ref K822928

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Beta I Programmable Infusion Pump Ref K831897

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Click-Count U100 Insulin Syringe Ref K833706

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Beta Scan Reagent Strip Ref K832691

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Neocath 1000 W/Hepcote Ref K832793

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Beta Scan Trends Meter Ref K851822

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Trends Lancet Ref K843882

    Active Regimes: 510(k) Registry: 510(k) Class:I
  • Betaject Bd U100 Ref K833705

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Beta Scan Drystix Ref K841369

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Beta Scan Normal Control Solution Ref K831523

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

Rows 1-12 of 12

Frequently asked questions

How many devices does Orange Medical Instruments, Inc. have in the registry?

The registry currently lists 12 devices for Orange Medical Instruments, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Orange Medical Instruments, Inc.'s devices?

Among its 12 most recently registered devices, Orange Medical Instruments, Inc. has devices listed in FDA 510(k) (12 devices).

What risk classes do Orange Medical Instruments, Inc.'s devices fall under?

Among its 12 most recently registered devices, the classes recorded for Orange Medical Instruments, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Orange Medical Instruments, Inc. in the registry?

The most recently registered devices listed for Orange Medical Instruments, Inc. include MICRO-BETA U100 SYRINGE, CONTINUCATH, DISPOSABLE MICRO-INFUSION SYSTEM and BETA I PROGRAMMABLE INFUSION PUMP.

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