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

SYSTEM, HEMOGLOBIN, AUTOMATED (GKR) (9) ASSAY, CARBOXYHEMOGLOBIN (GHS) (9) ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH (CHL) (9) ELECTRODE, ION SPECIFIC, CALCIUM (JFP) (9) ELECTRODE, ION SPECIFIC, POTASSIUM (CEM) (9) ELECTRODE, ION SPECIFIC, SODIUM (JGS) (9) ELECTRODE, ION-SPECIFIC, CHLORIDE (CGZ) (9) GLUCOSE OXIDASE, GLUCOSE (CGA) (9) Multi-analyte controls, all kinds (assayed) (JJY) (9) Oximeter (DQA) (8) CALIBRATOR, MULTI-ANALYTE MIXTURE (JIX) (7) DEVICE, HEMATOCRIT MEASURING (JPI) (7) ASSAY, FETAL HEMOGLOBIN (KQI) (2) BILIRUBIN (TOTAL AND UNBOUND) IN THE NEONATE TEST SYSTEM (MQM) (2) ACID, LACTIC, ENZYMATIC METHOD (KHP) (2) OXIMETER TO MEASURE HEMOGLOBIN (GLY) (2) ANALYZER, ENZYME, FOR CLINICAL USE (JJI) (2) MONITOR, CARBON-DIOXIDE, CUTANEOUS (LKD) (1) Oximeter, ear (DPZ) (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)

Premarket Exempt

Clear

tc Sensor 84 - 05700699457370 Catalog Number : 945-737

Device Description : tc Sensor 84, pCO2/pO2

Device Class : 2

Duns Number: 308667539

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

ABL80 SC80 - 05700699457684 Catalog Number : 945-768

Device Description : SC80 25/30 Full, QC3

Device Class : 1

Duns Number: 308667539

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

ABL80 SC80 - 05700699457691 Catalog Number : 945-769

Device Description : SC80 25/30 Full, no GLU, QC3

Device Class : 1

Duns Number: 308667539

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

ABL80 SC80 - 05700699457707 Catalog Number : 945-770

Device Description : SC80 25/30 BG/Hct, QC3

Device Class : 1

Duns Number: 308667539

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

ABL80 SC80 - 05700699457714 Catalog Number : 945-771

Device Description : SC80 25/30 Full, no QC3

Device Class : 1

Duns Number: 308667539

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

ABL80 SC80 - 05700699457738 Catalog Number : 945-773

Device Description : SC80 25/30 BG/Hct, no QC3

Device Class : 1

Duns Number: 308667539

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

ABL80 SC80 - 05700699458063 Catalog Number : 945-806

Device Description : SC80 600/60 CO-OX for OSM SW

Device Class : 1

Duns Number: 308667539

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

ABL80 SC80 - 05700699458438 Catalog Number : 945-843

Device Description : SC80 200/60 for FLEX, CO-OX,OSM version

Device Class : 1

Duns Number: 308667539

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

ABL90 Sensor Cassette pack - 05700699460059 Catalog Number : 946-005

Device Description : Sensor cassette SC90 300BG, LYT, MET, OXI + QC for ABL90. 300 tests, Blood gas. Sensor cassette SC90 300BG, LYT, MET, OXI + QC for ABL90. 300 tests, Blood gas. Electrolytes, Metabolites, CO-OX, Including Auto QC

Device Class : 1

Duns Number: 308667539

Premarket Exempt : No

Product Code : CHL, CEM, CGA, JGS, KQI, KHP, JFP, GKR, JJY, MQM, JIX, CGZ, GHS

Prescription Use : Yes

Device Count : 1

ABL90 Sensor Cassette pack - 05700699460080 Catalog Number : 946-008

Device Description : Sensor cassette SC90 600 BG, LYT, MET, OXI + QC for ABL90. 600 tests. Blood gas, Sensor cassette SC90 600 BG, LYT, MET, OXI + QC for ABL90. 600 tests. Blood gas, Electrolytes, Metabolites, CO-OX, Including Auto QC

Device Class : 1

Duns Number: 308667539

Premarket Exempt : No

Product Code : CHL, JIX, KHP, GHS, KQI, CGA, GKR, CEM, JJY, JGS, JFP, CGZ, MQM

Prescription Use : Yes

Device Count : 1

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