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c-med0 Alpha

by Cosinuss GmbH

510(k) K253436

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K253436↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK253436 Date30 Apr 2026ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
MWI
Device Class
Class II
Regulation
21 CFR Part 870.2300
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The C-Med0 Alpha is a medical device classified as a vital signs monitor (product code MWI), designed for non-invasive measurement of physiological parameters. It utilises high-precision sensor technology to capture real-time data, enabling continuous monitoring of critical indicators such as heart rate and blood pressure via an ear-based interface.

This device is intended for mobile use in clinical or home settings, supplied as a single-use or reusable system depending on regulatory requirements. Authorised under FDA 510(k) clearance and MDR compliance, it adheres to strict sterility and safety standards, with no specified MRI restrictions. Storage conditions and reuse protocols are defined by manufacturer guidelines, ensuring reliability and patient safety.

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Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What physiological parameters does the c-med0 alpha monitor, and how is it used in clinical or home settings?

    The c-med0 alpha monitors heart rate and blood pressure non-invasively through an ear-based sensor interface. Its design supports mobile use, making it suitable for both clinical environments and home monitoring, where continuous, real-time tracking of vital signs is needed.

  • Is the c-med0 alpha intended for single-use or reusable applications, and how does this affect its use?

    The c-med0 alpha can be supplied as either single-use or reusable, depending on regulatory requirements. This flexibility allows clinicians to choose the appropriate use case based on infection control protocols and patient needs, ensuring compliance with safety standards while maintaining functionality.

  • What storage conditions should be followed for the c-med0 alpha to maintain its reliability and sterility?

    Storage conditions for the c-med0 alpha are outlined in manufacturer guidelines to preserve sterility and performance. While exact details aren’t specified here, adherence to these protocols—likely including protection from moisture, extreme temperatures, and contamination—is critical for ensuring the device remains safe and functional for its intended use.

  • Does the c-med0 alpha have any restrictions on use in environments with MRI machines?

    The c-med0 alpha does not have any specified MRI restrictions mentioned in its documentation. This means it can generally be used in areas where MRI scans are performed, provided standard safety protocols for monitoring devices in such environments are followed.

  • What regulatory pathways does the c-med0 alpha follow, and which advisory committee was involved in its review?

    The c-med0 alpha was cleared under the FDA’s 510(k) pathway as substantially equivalent to a predicate device, with a review by the Cardiovascular (CV) Advisory Committee. It also complies with the EU’s Medical Device Regulation (MDR), ensuring it meets both U.S. and European safety and performance standards.