Radiometer Solutions Sp. z o.o.

Registration Details

Registration Name: Radiometer Solutions Sp. z o.o.
Registration Number: 3013513377
FEI Number: 3013513377
Status: Active
Expiry Year: 2026
Initial Importer: No
Address: Stalowa 6
City: Stargard Zachodniopomorskie
Country: PL

Regulatory Submissions

510(k) Number: K130236

Owner / Operator

Firm Name: RADIOMETER MEDICAL APS
Operator Number: 8020503
Address: AAKANDEVEJ 21, --
City: BROENSHOEJ
State: Hovedstaden
Postal Code: 2700
Country: DK
Correspondent: Hsiao-Qing Chow

US Agent

Business Name: RADIOMETER AMERICA, INC.
Contact Name: MATT ACKERMAN
Address: 250 S Kraemer Blvd
City: Brea
State: CA
ZIP: 92821
Country: US
Email: [email protected]
Phone: 657 2861022

Products

Device Name	Product Code	Device Class	Medical Specialty	Exempt	Created
Controls For Blood-Gases, (Assayed And Unassayed)	JJS	Class 1	Clinical Chemistry	No	2024-12-18
Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia	LPP	Class 2	Anesthesiology	No	2015-03-26
Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia	KLK	Class 2	Anesthesiology	No	2015-03-26
Monitor, Carbon-Dioxide, Cutaneous	LKD	Class 2	Anesthesiology	No	2015-03-26
Oximeter	DQA	Class 2	Cardiovascular	No	2015-03-26
Tubes, Vials, Systems, Serum Separators, Blood Collection	JKA	Class 2	Clinical Chemistry	No	2015-03-26
Syringe, Antistick	MEG	Class 2	General Hospital	No	2015-03-26
Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph	CHL	Class 2	Clinical Chemistry	No	2026-06-17
Assay, Carboxyhemoglobin	GHS	Class 2	Hematology	No	2026-06-17
System, Hemoglobin, Automated	GKR	Class 2	Hematology	No	2026-06-17
Electrode, Ion Specific, Potassium	CEM	Class 2	Clinical Chemistry	No	2017-02-07
Instrument, Hematocrit, Automated	GKF	Class 2	Hematology	No	2017-02-07
Diazo Colorimetry, Bilirubin	CIG	Class 2	Clinical Chemistry	No	2017-02-07
Electrode, Ion-Specific, Chloride	CGZ	Class 2	Clinical Chemistry	No	2017-02-07
Glucose Oxidase, Glucose	CGA	Class 2	Clinical Chemistry	No	2017-02-07
Electrode, Ion Specific, Calcium	JFP	Class 2	Clinical Chemistry	No	2017-02-07
Electrode, Ion Specific, Sodium	JGS	Class 2	Clinical Chemistry	No	2017-02-07
Acid, Lactic, Enzymatic Method	KHP	Class 1	Clinical Chemistry	No	2017-02-07
Electrode, Ion Based, Enzymatic, Creatinine	CGL	Class 2	Clinical Chemistry	No	2016-02-26
Assay, Fetal Hemoglobin	KQI	Class 2	Hematology	No	2017-04-21
Calibrator, Multi-Analyte Mixture	JIX	Class 2	Clinical Chemistry	No	2017-04-21
Bilirubin (Total And Unbound) In The Neonate Test System	MQM	Class 1	Clinical Chemistry	No	2017-04-21
Multi-Analyte Controls, All Kinds (Assayed)	JJY	Class 1	Clinical Chemistry	No	2017-04-21
Device, Hematocrit Measuring	JPI	Class 2	Hematology	No	2022-06-28
Oximeter, Ear	DPZ	Class 2	Cardiovascular	No	2016-09-02

Proprietary Names

Range+QUALICHECK LEVEL 1,2,3 High Metabolite QUALICHECK TCM4 Monitoring System TCM40 Monitoring System, ABL90 FLEX PLUS 944-075 S7745 AutoCheck 5+ Level 2 944-084 S7355 AutoCheck3+ Level 3 944-085 S7365 AutoCheck3+ Level 4 944-083 S7345 AutoCheck3+ Level 2 944-077 S7765 AutoCheck5+ Level 4 944-082 S7335 AutoCheck3+ Level 1 944-074 S7735 AutoCheck5+ Level 1 944-076 S7755 AutoCheck 5+ Level 3 safeCLINITUBES 944-064 S1720 Calibration Solution 1 909-590 D512 Disposable waste container 944-057 S4970 Rinse Solution Hematocrit and Metabolite QUALICHECK levels 1 and 2 ABL837 FLEX 905-802 D513 Disposable Waste Container 944-127 S1820 Calibration Solution 1 944-130 S4980 Rinse Solution 944-155 Rinse Solution II S4987 600mL 944-136 S8377 Cleaning Solution Met II Solution ABL90 FLEX ABL80 CO-OX ABL80 FLEX ABL80 FLEX CO-OX with AQURE 944-094 S7835 AutoCheck 6+ Level 1 944-097 S7865 AutoCheck 6+ Level 4 944-095 S7845 AutoCheck 6+ Level 2 944-096 S7855 AutoCheck 6+ Level 3 TCM TOSCA Monitoring System TCM CombiM Monitoring System

Establishment Types

Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device for Another Party (Contract Manufacturer)