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Eucardio Laboratory, Inc.

United StatesFDA 510(k) applicant, unverified

Devices
4

What Eucardio Laboratory, Inc. makes

Eucardio Laboratory, Inc. manufactures handheld inertial measurement units (IMUs) for medical monitoring, including the UC IMU A and UC IMU B, as well as rapid diagnostic tests for pregnancy detection, such as the UC QIK 1-STEP HCG Test and UC QIK Pregnancy Test.

These devices are classified as Class II under FDA regulations and are listed via 510(k) clearance. The company is based in the United States.

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

Catalogue4

Newest first, rows 1-4 of 4

  • Uc Imu B Ref K904137

    Class II
    Active 510(k) 510(k) II
  • Uc Qik 1-Step Hcg Test Ref K942464

    Class II
    Active 510(k) 510(k) II
  • Uc Imu A Ref K904125

    Class II
    Active 510(k) 510(k) II
  • Uc Qik Pregnancy Test Ref K926500

    Class II
    Active 510(k) 510(k) II

Frequently asked questions

How many devices does Eucardio Laboratory, Inc. have in the registry?

The registry currently lists 4 devices for Eucardio Laboratory, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Eucardio Laboratory, Inc.'s devices?

Among its 4 most recently registered devices, Eucardio Laboratory, Inc. has devices listed in FDA 510(k) (4 devices).

What risk classes do Eucardio Laboratory, Inc.'s devices fall under?

Among its 4 most recently registered devices, the classes recorded for Eucardio Laboratory, Inc.'s devices are Class II. Each device page shows its own class and authorisation.

What are the newest devices from Eucardio Laboratory, Inc. in the registry?

The most recently registered devices listed for Eucardio Laboratory, Inc. include UC IMU B, UC QIK 1-STEP HCG TEST, UC IMU A and UC QIK PREGNANCY TEST.

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