HomeGermanyGAMBRO DIALYSATOREN GMBH

GAMBRO DIALYSATOREN GMBH

Germany · Hechingen
✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Brazil, Canada, Taiwan, South Korea, Australia, Hong Kong, Israel, Russia — 9 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
7listed device types
Class I 0Class II 7Class III 0
plus 8 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
1registered devices
Class II 1
2 including historic records
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
1active device licences
Class III 1
10 including historic records
TWTaiwanTFDA
8valid device licences
Class II 6Class III 2
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
4GMP quality-system certificates
Import 4
AUAustraliaTGA ARTG
5active ARTG entries
IIb 5
HKHong KongMDACS
8valid listings
Class III 8
ILIsraelAMAR
9registrations
RURussiaRoszdravnadzor
4active registrations
Class 2b 4
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 States8 registration records, 0 510(k), 0 PMA
Brazil1 confirmed, 0 excluded
Canada1 confirmed, 0 excluded
Manufacturer names merged into this page: GAMBRO DIALYSATOREN GMBH · SECON ZWEIGNIEDERLASSUNG DER GAMBRO DIALYSATOREN GMBH & CO.KG

Company information

Country
Germany
City
Hechingen

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

Subsystem, Water Purification 1Set, Tubing, Blood, With And Without Anti-Regurgitation Valve 1Apparatus, Hemoperfusion, Sorbent 1Hemodialyzer With Expanded Solute Removal Profile 1Hemodialyzer, Re-Use, High Flux 1Dialyzer, High Permeability With Or Without Sealed Dialysate System 1Dialyzer, Capillary, Hollow Fiber 1

Registration details (sample)

MarketIdentifierNameClass / date
BR80145240417ULTRAFILTRO U9000Class II
CA12819ADSORBAClass III

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