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Home›Mexico›GAMBRO RENAL PRODUCTS S.A. DE C.V.

GAMBRO RENAL PRODUCTS S.A. DE C.V.

Mexico · Tijuana
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Canada, South Korea — 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
2listed device types
Class I 0Class II 2Class III 0
plus 4 registration records and 39 510(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
5active device licences
Class II 4Class III 1
13 including historic records
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
2GMP quality-system certificates
Import 2
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, 39 510(k), 0 PMA, 18 excluded
Canada5 confirmed, 2 excluded
Manufacturer names merged into this page: GAMBRO RENAL PRODUCTS S.A. DE C.V. · GAMBRO RENAL PRODUCTS - MANUFACTURING OPERATIONS DIVISION · GAMBRO RENAL PRODUCTS INC.
Same-named companies — This database also contains companies with near-identical names: Gambro Renal Care Products, Gambro Renal Products, Inc.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
Mexico
City
Tijuana

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

FDA 510(k) clearances by year

11999
12000
52001
32002
22003
32004
62005
22006
42007
22008
32010
22011
22012
12013
22014

FDA listed device types

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

Registration details (sample)

MarketIdentifierNameClass / date
USK133807MARS MONITOR ITC US, MARS TREATMENT KIT TYPE 1116/1 - X-MARS US, PRISMAFLEX CONTROL UNIT2014-03-26
USK131516PRISMAFLEX SYSTEM 7.102014-01-03
USK130039REVACLEAR 300 DIALYZER, REVACLEAR 400 DIALYZER2013-05-02
CA7693COBE CENTRYSYSTEM 3, SINGLE-NEEDLE CONVERSION KITClass II
CA12295CENTRYSYSTEM 3Class III
CA5337COBE TRANSDUCER PROTECTORClass II

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