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Cd Leycom BV

Netherlands · Hengelo Overijssel

✓ Record-verifiedregistrations found in 1 markets

This company has registrations in United States — 1 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

5listed device types

Class I 0Class II 5Class III 0

plus 3 registration records and 3 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

pendingnot queried

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States3 registration records, 3 510(k), 0 PMA

Manufacturer names merged into this page: CD LEYCOM

FDA 510(k) clearances by year

12001 · K003020

22003 · K031599

FDA listed device types

Amplifier And Signal Conditioner, Transducer Signal 1Catheter, Intravascular, Diagnostic 1Catheter, Ultrasound, Intravascular 1Pacemaker, Cardiac, External Transcutaneous (Non-Invasive) 1Transducer, Pressure, Catheter Tip 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K031599	CD LEYCOM PRESSURE/VOLUME CATHETERS	2003-12-09
US	K030524	CD LEYCOM 7 FR PRESSURE/VOLUME CATHETER (10 MM ELECTRODE SPACING) PRESSURE/VOLUME COMBINATION CATHETER WITH LUMEN	2003-03-03
US	K003020	CARDIAC FUNCTION LABORATORY; PRESSURE INTERFACE; PRESSURE / VOLUME CATHETER	2001-05-11

Cd Leycom BV

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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