Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3002807968

FEI Number

3002807968

Entity Name

RADIOMETER MEDICAL APS

City/State/Country

BROENSHOEJ Hovedstaden, DK

Establishment Address

AAKANDEVEJ 21, BROENSHOEJ Hovedstaden 2700, DK

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

Radiometer Medical ApS (Owner Number: 9064213)

Owner / Operator Contact Address

AAKANDEVEJ 21, --, BROENSHOEJ, DK-84 2700, DK

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K160153

PMA Number

N/A

All Registered Proprietary Names

ABL90 FLEX PLUS TCM400 Monitoring System ABL90 FLEX PLUS ABL90 FLEX PLUS ABL90 FLEX PLUS ABL90 FLEX PLUS ABL90 FLEX PLUS

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OUG	Medical Device Data System	General Hospital	Class 1	880.6310	2013-01-26
JFP	Electrode, Ion Specific, Calcium	Clinical Chemistry	Class 2	862.1145	2010-12-02
JGS	Electrode, Ion Specific, Sodium	Clinical Chemistry	Class 2	862.1665	2010-12-02
CHL	Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph	Clinical Chemistry	Class 2	862.1120	2010-12-02
KQI	Assay, Fetal Hemoglobin	Hematology	Class 2	864.7455	2010-12-02
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2010-12-02
KHP	Acid, Lactic, Enzymatic Method	Clinical Chemistry	Class 1	862.1450	2010-12-02
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2010-12-02
GKR	System, Hemoglobin, Automated	Hematology	Class 2	864.5620	2010-12-02
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2010-12-02
CEM	Electrode, Ion Specific, Potassium	Clinical Chemistry	Class 2	862.1600	2010-12-02
CGZ	Electrode, Ion-Specific, Chloride	Clinical Chemistry	Class 2	862.1170	2010-12-02
GHS	Assay, Carboxyhemoglobin	Hematology	Class 2	864.7425	2010-12-02
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2026-05-13
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2012-12-21
MEG	Syringe, Antistick	General Hospital	Class 2	880.5860	2012-12-21
DPZ	Oximeter, Ear	Cardiovascular	Class 2	870.2710	2010-03-25
KLK	Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia	Anesthesiology	Class 2	868.2500	2010-03-25
LKD	Monitor, Carbon-Dioxide, Cutaneous	Anesthesiology	Class 2	868.2480	2010-03-25
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2010-03-25
LPP	Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia	Anesthesiology	Class 2	868.2500	2010-03-25
JJS	Controls For Blood-Gases, (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2013-12-13
JJS	Controls For Blood-Gases, (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2015-06-22
LPP	Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia	Anesthesiology	Class 2	868.2500	2013-01-28
CHL	Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph	Clinical Chemistry	Class 2	862.1120	2026-05-13
GKR	System, Hemoglobin, Automated	Hematology	Class 2	864.5620	2026-05-13
GHS	Assay, Carboxyhemoglobin	Hematology	Class 2	864.7425	2026-05-13
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2026-05-13
CHL	Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph	Clinical Chemistry	Class 2	862.1120	2026-05-13
GKR	System, Hemoglobin, Automated	Hematology	Class 2	864.5620	2026-05-13
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2012-12-21
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2026-05-13
JFP	Electrode, Ion Specific, Calcium	Clinical Chemistry	Class 2	862.1145	2026-05-13
KHP	Acid, Lactic, Enzymatic Method	Clinical Chemistry	Class 1	862.1450	2026-05-13
CEM	Electrode, Ion Specific, Potassium	Clinical Chemistry	Class 2	862.1600	2026-05-13
JGS	Electrode, Ion Specific, Sodium	Clinical Chemistry	Class 2	862.1665	2026-05-13
JJS	Controls For Blood-Gases, (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2012-12-21
CGL	Electrode, Ion Based, Enzymatic, Creatinine	Clinical Chemistry	Class 2	862.1225	2008-03-19
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2005-09-15
LPP	Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia	Anesthesiology	Class 2	868.2500	2005-09-15
LKD	Monitor, Carbon-Dioxide, Cutaneous	Anesthesiology	Class 2	868.2480	2005-09-15
KLK	Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia	Anesthesiology	Class 2	868.2500	2005-09-15
CGZ	Electrode, Ion-Specific, Chloride	Clinical Chemistry	Class 2	862.1170	2026-05-13
JFP	Electrode, Ion Specific, Calcium	Clinical Chemistry	Class 2	862.1145	2026-05-13
JGS	Electrode, Ion Specific, Sodium	Clinical Chemistry	Class 2	862.1665	2026-05-13
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2016-11-21
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2016-11-21
KQI	Assay, Fetal Hemoglobin	Hematology	Class 2	864.7455	2016-11-21
KHP	Acid, Lactic, Enzymatic Method	Clinical Chemistry	Class 1	862.1450	2016-11-21
JFP	Electrode, Ion Specific, Calcium	Clinical Chemistry	Class 2	862.1145	2016-11-21
CHL	Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph	Clinical Chemistry	Class 2	862.1120	2016-11-21
MQM	Bilirubin (Total And Unbound) In The Neonate Test System	Clinical Chemistry	Class 1	862.1113	2016-11-21
CGZ	Electrode, Ion-Specific, Chloride	Clinical Chemistry	Class 2	862.1170	2016-11-21
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2016-11-21
CEM	Electrode, Ion Specific, Potassium	Clinical Chemistry	Class 2	862.1600	2016-11-21
GKR	System, Hemoglobin, Automated	Hematology	Class 2	864.5620	2016-11-21
GHS	Assay, Carboxyhemoglobin	Hematology	Class 2	864.7425	2016-11-21
JGS	Electrode, Ion Specific, Sodium	Clinical Chemistry	Class 2	862.1665	2016-11-21

Official Correspondent

Hsiao-Qing Chow

US Agent Details

MATT ACKERMAN Business: RADIOMETER AMERICA, INC. Email: mackerman@radiometeramerica.com Phone: (657) 2861022

Related Public Records

Same Entity

Radiometer Medical ApS

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K884771	Instrumentation Laboratory CO	IL PHOENIX, MODEL 900, CHEMISTRY/ELECTROLYTE ANALY	1989-02-10
K840557	Shaban Mfg. Co.	REAGENTS & STANDARDS IL 501 NA/K	1984-04-04
K801007	Instrumentation Laboratory CO	IL SYSTEM 502 NA/K ANALYZER	1980-05-14
K760969	Instrumentation Laboratory CO	PH/BLOOD GAS SYSTEM	1977-01-12
K820744	Instrumentation Laboratory CO	IL MODEL 1301, PH BLOOD GAS SYSTEM	1982-04-15

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0148-2020	Siemens Healthcare Diagnostics, Inc.	2	Siemens Atellica CH 930 Analyzer. Siemens Material Number (SMN): 11067000 Product Usage: automated, clinical chemistry analyzer to perform in vitro diagnostic tests on clinical specimens
Z-0038-2008	Radiometer America Inc	2	Pump waste tube for blood gas analysis kit. One yellowish/white rubber tube per plastic bag. Used on ABL800 Flex Series blood gas analyzers.
Z-0778-2007	Instrumentation Laboratory Co.	2	GEM Premier 4000 Laboratory Analyzer
Z-0845-03	Instrumentation Laboratory Co.	2	GEM Premier 3000 Pak pH, pC02, pO2, Hct Sensor and Reagent Cartridge. Part No. 24330004 (300 Sample Size) For In-Vitro Diagnostic Use
Z-0846-03	Instrumentation Laboratory Co.	2	GEM Premier 3000 Pak Sensor pH, pC02, pO2, Hct and Reagent Cartridge. Part No. 24345004 (450 Sample Size) For In-Vitro Diagnostic Use

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3002807968. Last updated year: 2026. Please use registration number 3002807968 when referencing this establishment in official correspondence.