Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003493679

FEI Number

3003493679

Entity Name

CD LEYCOM

City/State/Country

Hengelo Overijssel, NL

Establishment Address

Asveldweg 2, Hengelo Overijssel 7556 BP, NL

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

CD Leycom (Owner Number: 9043127)

Owner / Operator Contact Address

ASVELDWEG 2, --, Hengelo, NL-NOTA 7556BP, NL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K003020

PMA Number

N/A

All Registered Proprietary Names

Cardiac Function Laboratory CD Leycom IntraCardiac Analyzer CFL-M Inca

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DRQ	Amplifier And Signal Conditioner, Transducer Signal	Cardiovascular	Class 2	870.2060	2007-12-28
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2007-12-28
DXO	Transducer, Pressure, Catheter Tip	Cardiovascular	Class 2	870.2870	2007-12-28

Official Correspondent

Dinant Goorhorst

US Agent Details

Mindy McCann Business: Qserve Group US Inc Email: USagent@qservegroup.com Phone: (424) 2718169

Related Public Records

Same Entity

CD Leycom

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K151126	Colibri Technologies, Inc.	Foresight Intracardiac Echocardiography (ICE) System	2015-12-18
K931629	Carapace, Inc.	CARAPACE ANGIOGRAPHY TRAYS	1993-12-06
K823758	Access Devices, Inc.	CENTRAL VEIN CATHERIZATION KIT	1983-02-23
K192019	ABBOTT MEDICAL	Dragonfly OpStar Imaging Catheter, AptiVue Software version E.5.1	2019-11-08
K230411	ABBOTT MEDICAL	Dragonfly OpStar Imaging Catheter	2023-04-14

Similar Registrations

Registration Number	Establishment Name	Location
3009077524	DHL SUPPLY CHAIN (NETHERLANDS) B.V.	Beringe Limburg, NL
2080783	NIHON KOHDEN AMERICA, INC.	Irvine, CA, US
9610816	Philips Medizin Systeme Boeblingen GmbH	BOEBLINGEN Baden-Wurttemberg, DE
1218950	Philips North America LLC	ANDOVER, MA, US
3007603826	Shenzhen Mindray Bio-Medical Electronics Co.,LTD	SHENZHEN Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003493679. Last updated year: 2026. Please use registration number 3003493679 when referencing this establishment in official correspondence.