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Cd Leycom BV

NetherlandsFDA applicant, unverified FDA

Cd Leycom BV is a medical device manufacturer, with 9 devices listed in FDA GUDID and FDA 510(k) (FDA Class II) as of 13 Nov 2026.

Devices
9
Registrations
FDA
FDA recalls
0

Registry facts

Counted by deviCERTS from registry records, 13 Nov 2026

Registries
  • FDA GUDID 6
  • FDA 510(k) 3

A device listed in two registries counts in both.

Device classes
  • FDA Class II 9

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA establishment

What Cd Leycom BV makes

Cd Leycom BV manufactures intracardiac catheters with pressure/volume measurement capabilities, including 4 Fr and 7 Fr pressure/volume combination catheters with integrated electrode spacing for cardiac assessment. Their portfolio also includes systems for cardiac function laboratories, designed to interface with pressure monitoring tools for diagnostic evaluations.

These devices are classified as Class II under FDA regulations and are listed in the FDA’s 510(k) and UDI registries.

AI-generated from registry data, 1 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue9

Newest first, rows 1-9 of 9

FDA establishments1

Registered with the FDA under this company group, matched by name.

  • Cd Leycom Hengelo Overijssel · NL FEI 3003493679

Frequently asked questions

How many devices does Cd Leycom BV have in the registry?

The registry currently lists 9 devices for Cd Leycom BV. Devices recorded under merged duplicate company entries are counted once.

Which registries list Cd Leycom BV's devices?

Among its 9 most recently registered devices, Cd Leycom BV has devices listed in FDA 510(k) (3 devices) and FDA GUDID (6 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do Cd Leycom BV's devices fall under?

Among its 9 most recently registered devices, the classes recorded for Cd Leycom BV's devices are Class II. Each device page shows its own class and authorisation.

What are the newest devices from Cd Leycom BV in the registry?

The most recently registered devices listed for Cd Leycom BV include Cardiac Function Laboratory CFL-M Inca, 7 Fr PV-Catheter CA-71083-PL, 7 Fr PV-Catheter CA-71103-PL and 7 Fr PV-Catheter CA-71123-PL.

Which FDA establishments are linked to Cd Leycom BV?

1 FDA establishment is linked to Cd Leycom BV in the registry; they are listed on the company page.

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