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Viasys Healthcare GmbH

Also registered as Viasys Healthcare, Inc.

Country not established

Devices
17

What Viasys Healthcare GmbH makes

Viasys Healthcare GmbH manufactures respiratory diagnostic devices, including pulse oximeters (e.g., SPIROPRO SPO2), spirometers (e.g., CLEAN PEAK FLOW METER, MASTERSCREEN PFT series), and portable cardiopulmonary exercise testing systems (e.g., MASTERSCREEN CPX, OXYCON CPX). Their portfolio also includes pediatric respiratory assessment tools (e.g., MASTERSCREEN PAED – BABY BODY) and screening devices for lung function and obstructive airway conditions (e.g., FLOWSCREEN, CORSCREEN). Additional products include flexible bronchoscopes (e.g., MASTERSCOPE) and diagnostic systems for assessing lung health in clinical and home settings.

The company’s devices are classified as Class II under FDA regulations and are supported by 510(k) clearance records. Their products are listed in the FDA’s 510(k) database, reflecting compliance with U.S. medical device authorization requirements. The manufacturer operates from the United States.

AI-generated from registry data, 3 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue17

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  • Spiropro SPO2 Ref K031515

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

  • Ball Recording Electrode/Stimulation Probe Ref K030517

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

  • Masterscreen Pneumo & Masterscope Ref K071753

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

  • Flowscreen, Flowscreen/Corscreen, Flowscreen Ct Ref K080734

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

  • Masterscreen Paed - Baby Body Ref K081823

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

  • Clean Peak Flow Meter Ref K091412

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

  • Masterscreen Pft, Masterscreen Pft Ct, Masterscreen Pft Body Ref K072061

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

  • Audiometer, Otoacoustic Emission, Auditory Branstem Response Access Ref K031713

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

  • Sonara; Sonara/Tek Ref K060421

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

  • Spiropro Ref K092324

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

  • Masterscreen Cpx And Oxycon Cpx Ref K040698

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

  • COR12+ Ref K091505

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

  • Corscreen Ref K070614

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

  • Masterscreen & Oxycon Cpx Ref K072323

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

  • Spirosoft Ref K031194

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

  • Vip Pulmonary Function System Ref K080510

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

  • Modification To Flowscreen Ref K062011

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

Rows 1-17 of 17

Frequently asked questions

How many devices does Viasys Healthcare GmbH have in the registry?

The registry currently lists 17 devices for Viasys Healthcare GmbH. Devices recorded under merged duplicate company entries are counted once.

Which registries list Viasys Healthcare GmbH's devices?

Among its 17 most recently registered devices, Viasys Healthcare GmbH has devices listed in FDA 510(k) (17 devices).

What risk classes do Viasys Healthcare GmbH's devices fall under?

Among its 17 most recently registered devices, the classes recorded for Viasys Healthcare GmbH's devices are Class II. Each device page shows its own class and authorisation.

What are the newest devices from Viasys Healthcare GmbH in the registry?

The most recently registered devices listed for Viasys Healthcare GmbH include SPIROPRO SPO2, BALL RECORDING ELECTRODE/STIMULATION PROBE, MASTERSCREEN PNEUMO & MASTERSCOPE and FLOWSCREEN, FLOWSCREEN/CORSCREEN, FLOWSCREEN CT.

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