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NEXUS MEDICAL, LLC

USA · Lenexa

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Canada — 2 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

7listed device types

Class I 1Class II 6Class III 0

plus 18 registration records and 16 510(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

6active device licences

Class II 6

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 States18 registration records, 16 510(k), 0 PMA, 13 excluded

Brazil0 confirmed, 2 excluded

Canada6 confirmed, 2 excluded

Manufacturer names merged into this page: NEXUS MEDICAL, LLC

FDA 510(k) clearances by year

12003

32004

12005

12006

22008

32010

12012

22013

12014

12015

FDA listed device types

Arthroscope 1System, Irrigation, Urological 1Tubes, Gastrointestinal (And Accessories) 1Set, I.V. Fluid Transfer 1Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass 1Set, Administration, Intravascular 1System, Blood Collection, Vacuum-Assisted, Manual 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K142590	All Safe Huber Safety Infusion Set	2015-01-16
US	K133351	NEXUS NIS-6P LUER ACTIVATED DEVICE	2014-05-22
US	K130879	NEXUS IV TUBING SET WITH LUER-ACCESSBILE ONE-WAY CHECK VALVE - IV PLUS	2013-07-09
CA	89674	NEXUS TKO	Class II
CA	89675	NEXUS TKO PRESSURE RATED EXTENSION SETS	Class II
CA	89676	NEXUS TKO EXTENSION SETS	Class II

NEXUS MEDICAL, LLC

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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