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

Oximeter (DQA) (8) Monitor, oxygen, cutaneous, for uses other than for infant not under gas anesthesia (LPP) (7) Monitor, oxygen, cutaneous, for infant not under gas anesthesia (KLK) (6) MONITOR, CARBON-DIOXIDE, CUTANEOUS (LKD) (6) ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH (CHL) (3) GLUCOSE OXIDASE, GLUCOSE (CGA) (3) ELECTRODE, ION SPECIFIC, CALCIUM (JFP) (3) ELECTRODE, ION SPECIFIC, SODIUM (JGS) (3) ELECTRODE, ION SPECIFIC, POTASSIUM (CEM) (3) ELECTRODE, ION-SPECIFIC, CHLORIDE (CGZ) (3) ASSAY, CARBOXYHEMOGLOBIN (GHS) (3) Oximeter, ear (DPZ) (3) SYSTEM, HEMOGLOBIN, AUTOMATED (GKR) (2) DEVICE, HEMATOCRIT MEASURING (JPI) (2) Multi-analyte controls, all kinds (assayed) (JJY) (2) DIAZO COLORIMETRY, BILIRUBIN (CIG) (1) CALIBRATOR, MULTI-ANALYTE MIXTURE (JIX) (1) BILIRUBIN (TOTAL AND UNBOUND) IN THE NEONATE TEST SYSTEM (MQM) (1) ACID, LACTIC, ENZYMATIC METHOD (KHP) (1) OXIMETER TO MEASURE HEMOGLOBIN (GLY) (1) ASSAY, FETAL HEMOGLOBIN (KQI) (1) ANALYZER, ENZYME, FOR CLINICAL USE (JJI) (1) ELECTRODE, ION BASED, ENZYMATIC, CREATININE (CGL) (1)

Premarket Exempt

Clear

ABL800 FLEX - 05700693938011 Catalog Number :

Device Description : ABL800 FLEX with crea

Device Class : 1

Duns Number: 308667539

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

ABL80 FLEX Analyzer - 05700693938394 Catalog Number : 393-839

Device Description : ABL80 FLEX Full panel, Analyzer

Device Class : 1

Duns Number: 308667539

Premarket Exempt : No

Product Code : CHL, GKR, GHS, CGZ, DQA, CEM, CGA, JJY, JPI, JGS, JFP, JIX

Prescription Use : Yes

Device Count : 1

ABL80 FLEX CO-OX Analyzer - 05700693938417 Catalog Number : 393-841

Device Description : ABL80 FLEX CO-OX, Analyzer

Device Class : 1

Duns Number: 308667539

Premarket Exempt : No

Product Code : CHL, JPI, DQA, CGA, JJI, GKR, GLY, JFP, CGZ, JJY, GHS, CEM, JGS

Prescription Use : Yes

Device Count : 1

Extension cable For TCM3 electrodes, 3m - 05700696178537 Catalog Number : 617-853

Device Description : Extension cable For TCM3 electrodes, 3m

Device Class : 2

Duns Number: 308667539

Premarket Exempt : No

Product Code : LKD, LPP, DQA, KLK

Prescription Use : Yes

Device Count : 1

Extension cable For TCM3 electrodes, 6m - 05700696178643 Catalog Number : 617-864

Device Description : Extension cable For TCM3 electrodes, 6m

Device Class : 2

Duns Number: 308667539

Premarket Exempt : No

Product Code : LKD, KLK, LPP, DQA

Prescription Use : Yes

Device Count : 1

TCM4XX ETX Serial adapter, cable for TCM4XX ETX - 05700696366491 Catalog Number : 636-649

Device Description : TCM4XX ETX Serial adapter, cable for TCM4XX ETX

Device Class : 2

Duns Number: 308667539

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

TCM4XX ETX Analog adapter cable for TCM4XX ETX - 05700696366507 Catalog Number : 636-650

Device Description : TCM4XX ETX Analog adapter cable for TCM4XX ETX

Device Class : 2

Duns Number: 308667539

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

TCM4XX ETX VueLink adapter, cable for TCM4XX ETX - 05700696366514 Catalog Number : 636-651

Device Description : TCM4XX ETX VueLink adapter, cable for TCM4XX ETX

Device Class : 2

Duns Number: 308667539

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

O2 module for the TCM4XX Series - 05700699025647 Catalog Number : 902-564

Device Description : O2 module for the TCM4XX Series

Device Class : 2

Duns Number: 308667539

Premarket Exempt : No

Product Code : LPP

Prescription Use : Yes

Device Count : 1

TCM4 combi module, TCpO2/O2 combi module - 05700699027788 Catalog Number : 902-778

Device Description : TCM4 combi module, TCpO2/O2 combi module

Device Class : 2

Duns Number: 308667539

Premarket Exempt : No

Product Code : LKD, DQA, KLK, LPP

Prescription Use : Yes

Device Count : 1

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