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NXSTAGE MEDICAL, INC.

USA · Lawrence

✓ 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

11listed device types

Class I 1Class II 9Class III 0unclassified 1

plus 26 registration records and 51 510(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

3active device licences

Class II 3

11 including historic records

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 States26 registration records, 51 510(k), 0 PMA

Canada3 confirmed, 0 excluded

Manufacturer names merged into this page: NXSTAGE MEDICAL, INC. · NXSTAGE MEDICAL, INC. ALSO DBA MEDISYSTEMS CORPORATION

FDA 510(k) clearances by year

32001

52002

32003

52004

42005

22006

12007

32008

12009

12010

12011

12012

52013

72014

22015

22017

12018

12019

12023

22024

FDA listed device types

showing 8 of 11

Needle, Fistula 1Dialyzer, High Permeability With Or Without Sealed Dialysate System 1Dialysate Concentrate For Hemodialysis (Liquid Or Powder) 1Protector, Transducer, Dialysis 1Needle, Hypodermic, Single Lumen 1Monitor, Temperature, Dialysis 1Warmer, Thermal, Infusion Fluid 1Subsystem, Proportioning 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K232803	NxStage System One with Cartridge Express (CAR-170-E and CAR-172-E)	2024-03-14
US	K233213	NxStage PureFlow Solution	2024-01-18
US	K230632	VersiHD with GuideMe software	2023-08-11
CA	30621	ACCESS ALERT ACCESS PRESSURE MEASUREMENT GAUGE	Class II
CA	28223	STERILE FLUID RESERVOIRS	Class II
CA	28224	LIFEMATE MLA - MULTI-LINE-ADAPTOR	Class II

NXSTAGE MEDICAL, INC.

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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