Sinnowa · Rejestr IVDR

Wariant (UDI-DI)

UDI-DI	06971385381128
Secondary DI
Nr katalogowy	N/A
Status rynkowy	Na rynku UE
Pierwsze wprowadzenie	Belgia
Wersja EUDAMED	1
Rodzaj (EMDN)	IVD INSTRUMENTS › CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS › CHEMISTRY INSTRUMENTS › CHEMISTRY ANALYSERS › CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400); IVD INSTRUMENTS › CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS › CHEMISTRY INSTRUMENTS › CHEMISTRY ANALYSERS › CHEMISTRY ANALYSERS - MODERATE ROUTINE (Random access without ISE mode test/h > 400 and <= 800); IVD INSTRUMENTS › CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS › CHEMISTRY INSTRUMENTS › CHEMISTRY ANALYSERS › CHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Random access without ISE mode test/h > 800 and <= 1.200); IVD INSTRUMENTS › CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS › CHEMISTRY INSTRUMENTS › CHEMISTRY ANALYSERS › CHEMISTRY ANALYSERS - HIGH ROUTINE (Random access without ISE mode test/h > 1.200); IVD INSTRUMENTS › CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS › CHEMISTRY INSTRUMENTS › CHEMISTRY ANALYSERS › CHEMISTRY ANALYSERS - LOW ROUTINE (with ISE mode test/h <= 400); IVD INSTRUMENTS › CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS › CHEMISTRY INSTRUMENTS › CHEMISTRY ANALYSERS › CHEMISTRY ANALYSERS - MODERATE ROUTINE (with ISE mode test/h > 400 and <= 800); IVD INSTRUMENTS › CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS › CHEMISTRY INSTRUMENTS › CHEMISTRY ANALYSERS › CHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (with ISE mode test/h > 800 and <= 1.200); IVD INSTRUMENTS › CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS › CHEMISTRY INSTRUMENTS › CHEMISTRY ANALYSERS › CHEMISTRY ANALYSERS - HIGH ROUTINE (with ISE mode test/h > 1.200); IVD INSTRUMENTS › CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS › CHEMISTRY INSTRUMENTS › CHEMISTRY ANALYSERS › CHEMISTRY ANALYSERS - HARDWARE ACCESSORIES; IVD INSTRUMENTS › CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS › CHEMISTRY INSTRUMENTS › CHEMISTRY ANALYSERS › CHEMISTRY ANALYSERS - SOFTWARE ACCESSORIES; IVD INSTRUMENTS › CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS › CHEMISTRY INSTRUMENTS › CHEMISTRY ANALYSERS › CHEMISTRY ANALYSERS - CONSUMABLES; IVD INSTRUMENTS › CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS › CHEMISTRY INSTRUMENTS › CHEMISTRY ANALYSERS › CHEMISTRY ANALYSERS - IVD MEDICAL DEVICE SOFTWARE
Kody EMDN	W0201010101 CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400) W0201010102 CHEMISTRY ANALYSERS - MODERATE ROUTINE (Random access without ISE mode test/h > 400 and <= 800) W0201010103 CHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Random access without ISE mode test/h > 800 and <= 1.200) W0201010104 CHEMISTRY ANALYSERS - HIGH ROUTINE (Random access without ISE mode test/h > 1.200) W0201010105 CHEMISTRY ANALYSERS - LOW ROUTINE (with ISE mode test/h <= 400) W0201010106 CHEMISTRY ANALYSERS - MODERATE ROUTINE (with ISE mode test/h > 400 and <= 800) W0201010107 CHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (with ISE mode test/h > 800 and <= 1.200) W0201010108 CHEMISTRY ANALYSERS - HIGH ROUTINE (with ISE mode test/h > 1.200) W0201010180 CHEMISTRY ANALYSERS - HARDWARE ACCESSORIES W0201010182 CHEMISTRY ANALYSERS - SOFTWARE ACCESSORIES W0201010185 CHEMISTRY ANALYSERS - CONSUMABLES W0201010192 CHEMISTRY ANALYSERS - IVD MEDICAL DEVICE SOFTWARE

Wyrób (Basic UDI-DI)

Basic UDI-DI	697138538BA001AZ
Nazwa wyrobu	Biochemistry Analyzer
Model	DS-161, DS-261, DS- 301, DS-401,DS- 405,DS-612，DS- 812,BS-3000M，BS- 3000P,BS-3000,CH- 12，CH-24
Klasa ryzyka	Klasa A
Podstawa prawna	IVDR
Typ	analizator
Użytek profesjonalny	tak