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GAMBRO RENAL PRODUCTS - MANUFACTURING OPERATIONS DIVISION

USA · Lakewood

✓ 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

2listed device types

Class I 0Class II 2Class III 0

plus 4 registration records and 41 510(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

11active device licences

Class II 6Class III 5

19 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 States4 registration records, 41 510(k), 0 PMA, 17 excluded

Canada11 confirmed, 1 excluded

Manufacturer names merged into this page: GAMBRO RENAL PRODUCTS S.A. DE C.V. · GAMBRO RENAL PRODUCTS - MANUFACTURING OPERATIONS DIVISION · BAXTER HEALTHCARE CORPORATION RENAL DIVISION · GAMBRO RENAL PRODUCTS INC.

FDA 510(k) clearances by year

11999

12000

52001

32002

22003

32004

62005

22006

42007

22008

42010

22011

32012

12013

22014

FDA listed device types

Set, Tubing, Blood, With And Without Anti-Regurgitation Valve 1System, Peritoneal, Automatic Delivery 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K133807	MARS MONITOR ITC US, MARS TREATMENT KIT TYPE 1116/1 - X-MARS US, PRISMAFLEX CONTROL UNIT	2014-03-26
US	K131516	PRISMAFLEX SYSTEM 7.10	2014-01-03
US	K130039	REVACLEAR 300 DIALYZER, REVACLEAR 400 DIALYZER	2013-05-02
CA	7693	COBE CENTRYSYSTEM 3, SINGLE-NEEDLE CONVERSION KIT	Class II
CA	12295	CENTRYSYSTEM 3	Class III
CA	5337	COBE TRANSDUCER PROTECTOR	Class II

GAMBRO RENAL PRODUCTS - MANUFACTURING OPERATIONS DIVISION

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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