Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007490412

FEI Number

3007490412

Entity Name

Radiometer Sp. z o.o

City/State/Country

Stargard Zachodniopomorskie, PL

Establishment Address

ul. Podmiejska 3, Stargard Zachodniopomorskie 73-110, PL

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

RADIOMETER MEDICAL APS (Owner Number: 8020503)

Owner / Operator Contact Address

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

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

ABL90 FLEX PLUS ABL800 Flex Series ABL90 FLEX PLUS ABL90 FLEX PLUS ABL837 FLEX ABL90 FLEX PLUS safeCLINITUBES ABL90 FLEX PLUS TCM TOSCA Monitoring System TCM CombiM Monitoring System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JGS	Electrode, Ion Specific, Sodium	Clinical Chemistry	Class 2	862.1665	2026-06-17
CGZ	Electrode, Ion-Specific, Chloride	Clinical Chemistry	Class 2	862.1170	2026-06-17
JFP	Electrode, Ion Specific, Calcium	Clinical Chemistry	Class 2	862.1145	2026-06-17
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2015-03-25
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2015-03-26
MEG	Syringe, Antistick	General Hospital	Class 2	880.5860	2015-03-26
JFP	Electrode, Ion Specific, Calcium	Clinical Chemistry	Class 2	862.1145	2016-02-26
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2026-06-17
KQI	Assay, Fetal Hemoglobin	Hematology	Class 2	864.7455	2017-04-21
CHL	Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph	Clinical Chemistry	Class 2	862.1120	2017-04-21
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2017-04-21
KHP	Acid, Lactic, Enzymatic Method	Clinical Chemistry	Class 1	862.1450	2017-04-21
GHS	Assay, Carboxyhemoglobin	Hematology	Class 2	864.7425	2017-04-21
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2017-04-21
MQM	Bilirubin (Total And Unbound) In The Neonate Test System	Clinical Chemistry	Class 1	862.1113	2017-04-21
CEM	Electrode, Ion Specific, Potassium	Clinical Chemistry	Class 2	862.1600	2017-04-21
GKR	System, Hemoglobin, Automated	Hematology	Class 2	864.5620	2017-04-21
CGZ	Electrode, Ion-Specific, Chloride	Clinical Chemistry	Class 2	862.1170	2017-04-21
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2017-04-21
JFP	Electrode, Ion Specific, Calcium	Clinical Chemistry	Class 2	862.1145	2017-04-21
JGS	Electrode, Ion Specific, Sodium	Clinical Chemistry	Class 2	862.1665	2017-04-21
CGL	Electrode, Ion Based, Enzymatic, Creatinine	Clinical Chemistry	Class 2	862.1225	2016-02-26
GKR	System, Hemoglobin, Automated	Hematology	Class 2	864.5620	2026-06-17
CHL	Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph	Clinical Chemistry	Class 2	862.1120	2026-06-17
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2026-06-17
CEM	Electrode, Ion Specific, Potassium	Clinical Chemistry	Class 2	862.1600	2026-06-17
KHP	Acid, Lactic, Enzymatic Method	Clinical Chemistry	Class 1	862.1450	2026-06-17
JFP	Electrode, Ion Specific, Calcium	Clinical Chemistry	Class 2	862.1145	2026-06-17
JGS	Electrode, Ion Specific, Sodium	Clinical Chemistry	Class 2	862.1665	2026-06-17
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2026-06-17
KLK	Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia	Anesthesiology	Class 2	868.2500	2016-09-02
LPP	Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia	Anesthesiology	Class 2	868.2500	2016-09-02
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2016-09-02
DPZ	Oximeter, Ear	Cardiovascular	Class 2	870.2710	2016-09-02
LKD	Monitor, Carbon-Dioxide, Cutaneous	Anesthesiology	Class 2	868.2480	2016-09-02
GIO	Tube, Collection, Capillary Blood	Hematology	Class 1	864.6150	2015-03-26

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 →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
9614470	RADIOMETER BASEL AG	BASEL Basel-Stadt, CH
3014506106	Radiometer Minneapolis	New Brighton, MN, US
3013513377	Radiometer Solutions Sp. z o.o.	Stargard Zachodniopomorskie, PL
1523456	RADIOMETER AMERICA, INC.	Middleburg Heights, OH, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
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
K884771	Instrumentation Laboratory CO	IL PHOENIX, MODEL 900, CHEMISTRY/ELECTROLYTE ANALY	1989-02-10
K945777	Smiths Industries Medical Systems, Inc.	PRO-VENT(TM), PULSATOR(R), AND LINE DRAW(TM) ARTERIAL BLOOD SAMPLING SYRINGES	1994-12-22
K092413	Inviro Medical Devices, Inc.	INVIROSNAP 50 AND 100 UNIT INSULIN SAFETY SYRINGES	2009-09-04

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-0030-2014	Perkin Elmer Health Sciences, Inc.	2	Perkin Elmer 226 Sample Collection Device, Serial numbers: 06132903 - 06198900. The PerkinElmer 226 Sample Collection Devices are intended to be used as a medium to collect and transport whole blood specimen spots to a laboratory, in newborn screening. The device includes a tear-apart form for the collection of demographic information.
Z-0378-06	Instrumentation Laboratory Co.	2	GEM PREMIER 3000
Z-2165-2011	Instrumentation Laboratory Co.	2	Instrumentation Laboratory GEM Premier 4000 PN 00025000000 The GEM Premier 4000 is a portable critical care system for use by health care professionals to rapidly analyze whole blood samples at the point of health care delivery in a clinical setting and in a central laboratory. The instrument provides quantitative measurements of pH, pC02, p02, sodium, potassium, chloride, ionized calcium, glucose, lactate, hematocrit, total bilirubin and CO-OXimetry (tHb, 02Hb, COHb, MetHb, HHb) parameters. Total bilirubin can also be quantitated from heparinized plasma samples when analyzed in the tBili/CO-Ox mode. These parameters, along with derived parameters, aid in the diagnosis of a patient's acidlbase status, electrolyte and metabolite balance and oxygen delivery capacity. Total bilirubin measurements are used in the diagnosis and management of biliary tract obstructions, liver disease and various hemolytic diseases and disorders involving the metabolism of bilirubin. In neonates, the level of total bilirubin is used to aid in assessing the risk of kernicterus
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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007490412. Last updated year: 2026. Please use registration number 3007490412 when referencing this establishment in official correspondence.