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WATERS MEDICAL SYSTEMS, LLC

USA · Rochester

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Canada — 3 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 1Class II 4Class III 0

plus 11 registration records and 3 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

3registered devices

Class II 3

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

3 including historic records

TWTaiwanTFDA

0valid device licences

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 States11 registration records, 3 510(k), 0 PMA, 8 excluded

Brazil3 confirmed, 2 excluded

Canada0 confirmed, 1 excluded

Manufacturer names merged into this page: WATERS MEDICAL SYSTEMS, LLC · WATERS MEDICAL SYSTEMS LLC

FDA 510(k) clearances by year

12012 · K111521

22013 · K121736

FDA listed device types

Set, Perfusion, Kidney, Disposable 1System And Accessories, Isolated Heart, Transport And Preservation 1System, Perfusion, Kidney 1Oximeter 1Single (Specified) Analyte Controls (Assayed And Unassayed) 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K121736	PERF-GEN PULSATILE PERFUSION SOLUTION	2013-08-16
US	K121618	BEL-GEN COLD STORAGE SOLUTION	2013-06-14
US	K111521	WAVES	2012-02-16
BR	80672509001	WAVES	Class II
BR	80672500006	KIT MÓDULO CASSETE WAVES	Class II
BR	80672509009	RM3 - Sistema de Preservação Renal	Class II

WATERS MEDICAL SYSTEMS, 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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