HomeUSAGAMBRO UF SOLUTIONS, INC.

GAMBRO UF SOLUTIONS, INC.

USA · Plymouth
✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Brazil, Canada, Australia, Israel, Russia — 6 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
4listed device types
Class I 1Class II 3Class III 0
plus 12 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
2registered devices
Class I 2
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
4 including historic records
TWTaiwanTFDA
0valid device licences
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
3active ARTG entries
Class I 1Class Is (sterile) 2
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
2registrations
RURussiaRoszdravnadzor
1active registrations
Class 1 1
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 States12 registration records, 0 510(k), 0 PMA, 1 excluded
Brazil2 confirmed, 0 excluded
Manufacturer names merged into this page: Gambro UF Solutions LLC · GAMBRO UF SOLUTIONS, INC. · GAMBRO UF SOLUTIONS INC.

Company information

Country
USA
City
Plymouth

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 listed device types

Dialyzer, High Permeability With Or Without Sealed Dialysate System 1Set, Administration, For Peritoneal Dialysis, Disposable 1System, Peritoneal, Automatic Delivery 1Clamp, Line 1

Registration details (sample)

MarketIdentifierNameClass / date
BR80145240448Dreno extensor auto-efluenteClass I
BR80145240449Kit Auto-efluenteClass I

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