Hemocue AB

Address:KUVETTGATAN 1,ANGELHOLM Skane,SE

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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

System, Hemoglobin, Automated (GKR) (9) Counter, Cell, Automated (Particle Counter) (GKL) (1)

Premarket Exempt

No Yes

Clear

HemoCue® Hb 201 Microcuvettes - 17311091117165 Catalog Number : 111716

Device Description : HemoCue Hb 201 Microcuvettes 4x50 vial

Device Class :

Duns Number: 356164426

Premarket Exempt : No

Product Code : GKR

Prescription Use : Yes

Device Count : 50

HemoCue® Hb 201 Microcuvettes - 17311091117318 Catalog Number : 111731

Device Description : HemoCue Hb 201 Microcuvettes 4x50 vial

Device Class :

Duns Number: 356164426

Premarket Exempt : No

Product Code : GKR

Prescription Use : Yes

Device Count : 50

HemoCue® Hb 201 Microcuvettes - 17311091117325 Catalog Number : 111732

Device Description : HemoCue Hb 201 Microcuvettes 4x25 single

Device Class : 2

Duns Number: 356164426

Premarket Exempt : No

Product Code : GKR

Prescription Use : Yes

Device Count : 1

HemoCue® Hb 301 Microcuvettes - 17311091118018 Catalog Number : 111801

Device Description : HemoCue Hb 301 Microcuvettes 4x50 vial

Device Class :

Duns Number: 356164426

Premarket Exempt : No

Product Code : GKR

Prescription Use : Yes

Device Count : 50

HemoCue® Hb 301 Microcuvettes - 17311091118070 Catalog Number : 111807

Device Description : HemoCue Hb 301 Microcuvettes 4x75 vial

Device Class :

Duns Number: 356164426

Premarket Exempt : No

Product Code : GKR

Prescription Use : Yes

Device Count : 75

HemoCue® Hb 301 Microcuvettes - 17311091118094 Catalog Number : 111809

Device Description : HemoCue Hb 301 Microcuvettes 4x50 vial

Device Class :

Duns Number: 356164426

Premarket Exempt : No

Product Code : GKR

Prescription Use : Yes

Device Count : 50

HemoCue® Hb 301 Microcuvettes - 17311091118124 Catalog Number : 111812

Device Description : HemoCue Hb 301 Microcuvettes 4x50 vial

Device Class : 2

Duns Number: 356164426

Premarket Exempt : No

Product Code : GKR

Prescription Use : Yes

Device Count : 50

HemoCue® Hb 801 Microcuvettes - 17311091119022 Catalog Number : 111902

Device Description : HemoCue Hb 801 Microcuvettes 4x50 vial

Device Class :

Duns Number: 356164426

Premarket Exempt : No

Product Code : GKR

Prescription Use : Yes

Device Count : 50

HemoCue® WBC Microcuvettes - 17311091130034 Catalog Number : 113003

Device Description : HemoCue WBC Microcuvettes 4x40 vial

Device Class :

Duns Number: 356164426

Premarket Exempt : No

Product Code : GKL

Prescription Use : Yes

Device Count : 40

HemoCue® Hb301 Analyzer - 17311091218046 Catalog Number : 121804

Device Description : HemoCue Hb301 Analyzer g/dL

Device Class : 2

Duns Number: 356164426

Premarket Exempt : No

Product Code : GKR

Prescription Use : Yes

Device Count : 1

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