Eurotrol B.V.

Address:KEPLERLAAN 20,EDE Gelderland,NL

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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

Control, Hemoglobin (GGM) (5)

Premarket Exempt

No Yes

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CueSee® CO-OX - 08718734961567 Catalog Number : AN01718A05

Device Description : CueSee® CO-OX S2B is an unassayed material for professional use containing total CueSee® CO-OX S2B is an unassayed material for professional use containing total hemoglobin (tHb) with fractions of oxygenated hemoglobin (FO2Hb), fractions of carboxyhemoglobin (FCOHb) and fractions of methemoglobin (FMetHb).CueSee® CO-OX is intended for professional users (medical and laboratory personnel) in clinical settings (e.g. hospital or laboratory).

Device Class : 2

Duns Number: 412925992

Premarket Exempt : Yes

Product Code : GGM

Prescription Use : Yes

Device Count : 1

CueSee® CO-OX - 08718734961574 Catalog Number : AN01718A02

Device Description : CueSee® CO-OX S3B is an unassayed material for professional use containing total CueSee® CO-OX S3B is an unassayed material for professional use containing total hemoglobin (tHb) with fractions of oxygenated hemoglobin (FO2Hb), fractions of carboxyhemoglobin (FCOHb) and fractions of methemoglobin (FMetHb).CueSee® CO-OX is intended for professional users (medical and laboratory personnel) in clinical settings (e.g. hospital or laboratory).

Device Class : 2

Duns Number: 412925992

Premarket Exempt : Yes

Product Code : GGM

Prescription Use : Yes

Device Count : 1

CueSee® CO-OX - 08718734961581 Catalog Number : AN01718A06

Device Description : CueSee® CO-OX S4B is an unassayed material for professional use containing total CueSee® CO-OX S4B is an unassayed material for professional use containing total hemoglobin (tHb) with fractions of oxygenated hemoglobin (FO2Hb), fractions of carboxyhemoglobin (FCOHb) and fractions of methemoglobin (FMetHb).CueSee® CO-OX is intended for professional users (medical and laboratory personnel) in clinical settings (e.g. hospital or laboratory).

Device Class : 2

Duns Number: 412925992

Premarket Exempt : Yes

Product Code : GGM

Prescription Use : Yes

Device Count : 1

CueSee® CO-OX - 08718734961598 Catalog Number : AN01718A03

Device Description : CueSee® CO-OX S5B is an unassayed material for professional use containing total CueSee® CO-OX S5B is an unassayed material for professional use containing total hemoglobin (tHb) with fractions of oxygenated hemoglobin (FO2Hb), fractions of carboxyhemoglobin (FCOHb) and fractions of methemoglobin (FMetHb).CueSee® CO-OX is intended for professional users (medical and laboratory personnel) in clinical settings (e.g. hospital or laboratory).

Device Class : 2

Duns Number: 412925992

Premarket Exempt : Yes

Product Code : GGM

Prescription Use : Yes

Device Count : 1

CueSee® CO-OX - 08718734961635 Catalog Number : AN01718A04

Device Description : CueSee® CO-OX LVB is an unassayed material for professional use containing total CueSee® CO-OX LVB is an unassayed material for professional use containing total hemoglobin (tHb) with fractions of oxygenated hemoglobin (FO2Hb), fractions of carboxyhemoglobin (FCOHb) and fractions of methemoglobin (FMetHb).CueSee® CO-OX is intended for professional users (medical and laboratory personnel) in clinical settings (e.g. hospital or laboratory). CueSee® CO-OX LVB contains: 1 bottle of CueSee® CO-OX S1B (DI: 08718734961550), 1 bottle of CueSee® CO-OX S2B (DI: 08718734961567), 1 bottle of CueSee® CO-OX S3B (DI: 08718734961574), 1 bottle of CueSee® CO-OX S4B (DI: 08718734961581), 1 bottle of CueSee® CO-OX S5B (DI: 08718734961598).

Device Class : 2

Duns Number: 412925992

Premarket Exempt : Yes

Product Code : GGM

Prescription Use : Yes

Device Count : 1

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