Radiometer Medical ApS

Address:AAKANDEVEJ 21,BROENSHOEJ Hovedstaden,DK

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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

ACID, LACTIC, ENZYMATIC METHOD (KHP) (3) ASSAY, CARBOXYHEMOGLOBIN (GHS) (3) ASSAY, FETAL HEMOGLOBIN (KQI) (3) BILIRUBIN (TOTAL AND UNBOUND) IN THE NEONATE TEST SYSTEM (MQM) (3) DIAZO COLORIMETRY, BILIRUBIN (CIG) (3) ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH (CHL) (3) ELECTRODE, ION BASED, ENZYMATIC, CREATININE (CGL) (3) ELECTRODE, ION SPECIFIC, CALCIUM (JFP) (3) ELECTRODE, ION SPECIFIC, POTASSIUM (CEM) (3) ELECTRODE, ION SPECIFIC, SODIUM (JGS) (3) ELECTRODE, ION-SPECIFIC, CHLORIDE (CGZ) (3) GLUCOSE OXIDASE, GLUCOSE (CGA) (3) MONITOR, CARBON-DIOXIDE, CUTANEOUS (LKD) (1) Monitor, oxygen, cutaneous, for infant not under gas anesthesia (KLK) (1) Monitor, oxygen, cutaneous, for uses other than for infant not under gas anesthesia (LPP) (1) Oximeter (DQA) (1) Oximeter, ear (DPZ) (1)

Premarket Exempt

Clear

Calibration Gas 2 - 05700699621702 Catalog Number : 962-170

Device Description : Calibration gas 2, 10bar on-board gas bottle

Device Class : 1

Duns Number: 308667539

Premarket Exempt : No

Product Code : CHL, GHS, CGA, JGS, CGZ, JFP, CIG, KHP, MQM, CGL, CEM, KQI

Prescription Use : Yes

Device Count : 1

Calibration gas 1 - 05700699621740 Catalog Number : 962-174

Device Description : Calibration gas 1, 34bar on-board gas bottle for USA and Canada

Device Class : 1

Duns Number: 308667539

Premarket Exempt : No

Product Code : CHL, CGZ, MQM, CGA, JFP, JGS, GHS, CIG, KQI, CEM, CGL, KHP

Prescription Use : Yes

Device Count : 1

Calibration Gas 2 - 05700699621757 Catalog Number : 962-175

Device Description : Calibration gas 2, 10bar on-board gas bottle for USA and Canada

Device Class : 1

Duns Number: 308667539

Premarket Exempt : No

Product Code : CHL, CGL, CGZ, GHS, MQM, CIG, JGS, KQI, CGA, CEM, KHP, JFP

Prescription Use : Yes

Device Count : 1

Calibration Gas - 05700699621887 Catalog Number : 962-188

Device Description : TCM4 CAL GAS

Device Class : 2

Duns Number: 308667539

Premarket Exempt : No

Product Code : LKD, LPP, DPZ, KLK, DQA

Prescription Use : Yes

Device Count : 1

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