Skip to content

Carefusion Germany 234 GmbH

GermanyFDA applicant, unverified

Devices
12

What Carefusion Germany 234 GmbH makes

Carefusion Germany 234 GmbH manufactures respiratory monitoring and diagnostic devices, including portable spirometers (Vyntus Walk), asthma monitoring systems (Asthma Monitor AM3), and ventilator management software (SENTRYSUITE product line). Their portfolio also includes pulmonary function testing systems (MICRO I, MICROLAB, MICROLOOP) and screening tools for respiratory conditions (MASTERSCREEN IOS). Additional offerings include a web-based interpretation platform (Sentry WEB SmartInterp) and a ventilator alarm monitoring system (MICROGARD II).

The company’s devices fall under Class II regulatory classification in the U.S. and are authorised via FDA 510(k) clearance. Their products are listed in the FDA’s 510(k) database, reflecting compliance with U.S. medical device regulations. The company is based in 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

Search and filter all 12 devices
Skip device list

  • Sentrysuite Product Line Ref K113813

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

  • Sentrysuite Product Line Ref K122699

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

  • Vyntus Walk Ref K142959

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

  • Vyntus / SentrySuite Product Line Ref K150810 Open recall

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

  • Micro I Ref K113096

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

  • Vyntus/ Sentrysuite Product Line Ref K133925

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

  • Sentrysuite Product Line Ref K111053

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

  • Microblab, Microloop Ref K141936

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

  • Masterscreen Ios Ref K101873

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

  • Sentry WEB SmartInterp Ref K153654

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

  • Asthma Monitor AM3 Ref K092890

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

  • Microgard Ii Ref K111408

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

Rows 1-12 of 12

Frequently asked questions

How many devices does Carefusion Germany 234 GmbH have in the registry?

The registry currently lists 12 devices for Carefusion Germany 234 GmbH. Devices recorded under merged duplicate company entries are counted once.

Which registries list Carefusion Germany 234 GmbH's devices?

Among its 12 most recently registered devices, Carefusion Germany 234 GmbH has devices listed in FDA 510(k) (12 devices).

What risk classes do Carefusion Germany 234 GmbH's devices fall under?

Among its 12 most recently registered devices, the classes recorded for Carefusion Germany 234 GmbH's devices are Class II. Each device page shows its own class and authorisation.

What are the newest devices from Carefusion Germany 234 GmbH in the registry?

The most recently registered devices listed for Carefusion Germany 234 GmbH include SENTRYSUITE PRODUCT LINE, Vyntus Walk, Vyntus / SentrySuite Product Line and MICRO I.

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