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GAMBRO DASCO S.P.A., MONITORS DIVISION

Italy · Medolla Modena

✓ 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

6listed device types

Class I 1Class II 5Class III 0

plus 10 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

3registered devices

Class I 1Class II 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

1active device licences

Class III 1

25 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 States10 registration records, 0 510(k), 0 PMA

Brazil3 confirmed, 0 excluded

Canada1 confirmed, 0 excluded

Manufacturer names merged into this page: GAMBRO DASCO S.P.A., BLOOD LINE DIVISION · GAMBRO DASCO S.P.A., MONITORS DIVISION · GAMBRO DASCO S.P.A. · GAMBRO DASCO S.P.A

Same-named companies — This database also contains companies with near-identical names: GAMBRO DASCO S.P.A., GAMBRO DASCO S.P.A., BLOOD LINE DIVISION. Company name alone cannot separate their registrations, so the figures below may include either.

FDA listed device types

System, Hemodialysis, Remote Accessories 1Subsystem, Water Purification 1Set, Tubing, Blood, With And Without Anti-Regurgitation Valve 1Dialyzer, High Permeability With Or Without Sealed Dialysate System 1Dialysate Concentrate For Hemodialysis (Liquid Or Powder) 1System, Peritoneal, Automatic Delivery 1

Registration details (sample)

Market	Identifier	Name	Class / date
BR	80145240420	LINHA DE SANGUE PARA REINFUSAO	Class II
BR	80145240429	LINHA EXTENSORA SP-420	Class II
BR	80145240433	BOLSA DE DRENAGEM PARA HEMODIALISE	Class I
CA	12710	HEMODIALYSIS MONITORS	Class III

GAMBRO DASCO S.P.A., MONITORS DIVISION

Registrations by market

How these numbers were verified

Company information

FDA listed device types

Registration details (sample)

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