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

Multi-Analyte Controls, All Kinds (Assayed) (JJY) (7) Single (Specified) Analyte Controls (Assayed And Unassayed) (JJX) (2) Controls For Blood-Gases, (Assayed And Unassayed) (JJS) (1)

Premarket Exempt

No Yes

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Eurotrol AlbuTrol - 08718734960621 Catalog Number : 189.001.002

Device Description : Eurotrol AlbuTrol® is an assayed albumin control intended for professional use i Eurotrol AlbuTrol® is an assayed albumin control intended for professional use in the verification of the precision and accuracy of the HemoCue® Albumin 201 system. Eurotrol AlbuTrol® is intended for the quantitative determination of albumin.

Device Class : 1

Duns Number: 412925992

Premarket Exempt : No

Product Code : JJX

Prescription Use : Yes

Device Count : 1

Eurotrol AlbuTrol - 08718734960645 Catalog Number : 189.002.002

Device Class : 1

Duns Number: 412925992

Premarket Exempt : No

Product Code : JJX

Prescription Use : Yes

Device Count : 1

CueSee® Hypoxic - 08718734960652 Catalog Number : 166.001.005

Device Description : CueSee® Hypoxic is a pre-tonometered bovine hemoglobin (Hb) quality control mate CueSee® Hypoxic is a pre-tonometered bovine hemoglobin (Hb) quality control material for professional use for monitoring blood gas analyzers’ performance of Oxygen partial pressure (pO2).

Device Class : 1

Duns Number: 412925992

Premarket Exempt : No

Product Code : JJS

Prescription Use : Yes

Device Count : 1

Eurotrol epoc GAS-ISE Metabolites - 08718734960737 Catalog Number : 266.001.010

Device Description : Eurotrol epoc® GAS-ISE Metabolites - Level 1 is a single use, assayed blood gas, Eurotrol epoc® GAS-ISE Metabolites - Level 1 is a single use, assayed blood gas, electrolyte and metabolite reference material for the qualitative verification of the precision and accuracy of the epoc® Blood Analysis System. The product is an in vitro diagnostic device, intended for professional laboratory personnel. Eurotrol epoc® GAS-ISE Metabolites - Level 1 is designed to test the following analytes: pH, pO2, pCO2, Na+, K+, Ca2+, Mg2+, Cl-, glucose, lactate, urea, creatinine and tCO2.

Device Class : 1

Duns Number: 412925992

Premarket Exempt : No

Product Code : JJY

Prescription Use : No

Device Count : 1

Eurotrol epoc GAS-ISE Metabolites - 08718734960751 Catalog Number : 266.002.010

Device Description : Eurotrol epoc® GAS-ISE Metabolites - Level 2 is a single use, assayed blood gas, Eurotrol epoc® GAS-ISE Metabolites - Level 2 is a single use, assayed blood gas, electrolyte and metabolite reference material for the qualitative verification of the precision and accuracy of the epoc® Blood Analysis System. The product is an in vitro diagnostic device, intended for professional laboratory personnel. Eurotrol epoc® GAS-ISE Metabolites - Level 2 is designed to test the following analytes: pH, pO2, pCO2, Na+, K+, Ca2+, Mg2+, Cl-, glucose, lactate, urea, creatinine and tCO2.

Device Class : 1

Duns Number: 412925992

Premarket Exempt : No

Product Code : JJY

Prescription Use : No

Device Count : 1

Eurotrol epoc GAS-ISE Metabolites - 08718734960775 Catalog Number : 266.003.010

Device Description : Eurotrol epoc® GAS-ISE Metabolites - Level 3 is a single use, assayed blood gas, Eurotrol epoc® GAS-ISE Metabolites - Level 3 is a single use, assayed blood gas, electrolyte and metabolite reference material for the qualitative verification of the precision and accuracy of the epoc® Blood Analysis System. The product is an in vitro diagnostic device, intended for professional laboratory personnel. Eurotrol epoc® GAS-ISE Metabolites - Level 3 is designed to test the following analytes: pH, pO2, pCO2, Na+, K+, Ca2+, Mg2+, Cl-, glucose, lactate, urea, creatinine and tCO2.

Device Class : 1

Duns Number: 412925992

Premarket Exempt : No

Product Code : JJY

Prescription Use : No

Device Count : 1

Eurotrol epoc GAS-ISE Metabolites - 08718734960799 Catalog Number : 266.006.010

Device Description : Eurotrol epoc® GAS-ISE Metabolites - Level 6 is a single use, assayed blood gas, Eurotrol epoc® GAS-ISE Metabolites - Level 6 is a single use, assayed blood gas, electrolyte and metabolite reference material for the qualitative verification of the precision and accuracy of the epoc® Blood Analysis System. The product is an in vitro diagnostic device, intended for professional laboratory personnel. Eurotrol epoc® GAS-ISE Metabolites - Level 6 is designed to test the following analytes: pH, pO2, pCO2, Na+, K+, Ca2+, Mg2+, Cl-, glucose, lactate, urea, creatinine and tCO2.

Device Class : 1

Duns Number: 412925992

Premarket Exempt : No

Product Code : JJY

Prescription Use : No

Device Count : 1

Eurotrol® epoc® Calibration Verification Fluids - 08718734960805 Catalog Number : 267.000.005

Device Description : Eurotrol® epoc® Calibration Verification Fluids is a single use, assayed blood g Eurotrol® epoc® Calibration Verification Fluids is a single use, assayed blood gas, electrolyte and metabolite reference material for the qualitative verification of the precision and accuracy of the epoc® Blood Analysis System. The product is an in vitro diagnostic device, intended for professional laboratory personnel. Eurotrol® epoc® Calibration Verification Fluids is designed to test the following analytes: pH, pO2, pCO2, Na+, K+, Ca2+, Mg2+, Cl-, glucose, lactate, urea, creatinine and tCO2.

Device Class : 1

Duns Number: 412925992

Premarket Exempt : No

Product Code : JJY

Prescription Use : No

Device Count : 1

Eurotrol - 08718734960874 Catalog Number :

Device Class : 1

Duns Number: 412925992

Premarket Exempt : No

Product Code : JJY

Prescription Use : No

Device Count : 1

Eurotrol - 08718734960898 Catalog Number :

Device Class : 1

Duns Number: 412925992

Premarket Exempt : No

Product Code : JJY

Prescription Use : No

Device Count : 1

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