QUANTA DIALYSIS TECHNOLOGIES LIMITED

Address:Fford Richard Davies,St Asaph Denbighshire,GB

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Dialyzer, High Permeability With Or Without Sealed Dialysate System (KDI) (2) Set, Tubing, Blood, With And Without Anti-Regurgitation Valve (FJK) (1) System, Hemodialysis, Remote Accessories (MON) (1)

Premarket Exempt

No Yes

Clear

SC+ Haemodialysis System - 05060497260016 Catalog Number :

Device Description : SC+ Blood Tube Set

Device Class : 2

Duns Number: 211298693

Premarket Exempt : No

Product Code : FJK

Prescription Use : Yes

Device Count : 1

SC+ Dialysate Cartridge - 05060497260047 Catalog Number :

Device Description : SC+ Dialysate Cartridge

Device Class : 2

Duns Number: 211298693

Premarket Exempt : No

Product Code : KDI

Prescription Use : Yes

Device Count : 1

Cart - 05060497260061 Catalog Number :

Device Class : 1

Duns Number: 211298693

Premarket Exempt : Yes

Product Code : MON

Prescription Use : Yes

Device Count : 1

SC+ Hemodialysis Machine - 05060497260085 Catalog Number :

Device Description : SC+ Hemodialysis Delivery Device

Device Class : 2

Duns Number: 211298693

Premarket Exempt : No

Product Code : KDI

Prescription Use : Yes

Device Count : 1

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