Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013513377

FEI Number

3013513377

Entity Name

Radiometer Solutions Sp. z o.o.

City/State/Country

Stargard Zachodniopomorskie, PL

Establishment Address

Stalowa 6, 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

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 ABL90 FLEX PLUS 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 ABL90 FLEX PLUS ABL90 FLEX PLUS 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 PLUS ABL90 FLEX ABL80 CO-OX ABL80 FLEX ABL90 FLEX

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JJS	Controls For Blood-Gases, (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2024-12-18
JJS	Controls For Blood-Gases, (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2024-12-18
LPP	Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia	Anesthesiology	Class 2	868.2500	2015-03-26
KLK	Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia	Anesthesiology	Class 2	868.2500	2015-03-26
LKD	Monitor, Carbon-Dioxide, Cutaneous	Anesthesiology	Class 2	868.2480	2015-03-26
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2015-03-26
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
CHL	Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph	Clinical Chemistry	Class 2	862.1120	2026-06-17
GHS	Assay, Carboxyhemoglobin	Hematology	Class 2	864.7425	2026-06-17
GKR	System, Hemoglobin, Automated	Hematology	Class 2	864.5620	2026-06-17
JJS	Controls For Blood-Gases, (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2017-02-07
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	2017-02-07
GKF	Instrument, Hematocrit, Automated	Hematology	Class 2	864.5600	2017-02-07
CIG	Diazo Colorimetry, Bilirubin	Clinical Chemistry	Class 2	862.1110	2017-02-07
CGZ	Electrode, Ion-Specific, Chloride	Clinical Chemistry	Class 2	862.1170	2017-02-07
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2017-02-07
JFP	Electrode, Ion Specific, Calcium	Clinical Chemistry	Class 2	862.1145	2017-02-07
CHL	Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph	Clinical Chemistry	Class 2	862.1120	2017-02-07
JGS	Electrode, Ion Specific, Sodium	Clinical Chemistry	Class 2	862.1665	2017-02-07
KHP	Acid, Lactic, Enzymatic Method	Clinical Chemistry	Class 1	862.1450	2017-02-07
JJS	Controls For Blood-Gases, (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2024-12-18
CGL	Electrode, Ion Based, Enzymatic, Creatinine	Clinical Chemistry	Class 2	862.1225	2016-02-26
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
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
CEM	Electrode, Ion Specific, Potassium	Clinical Chemistry	Class 2	862.1600	2016-11-25
MQM	Bilirubin (Total And Unbound) In The Neonate Test System	Clinical Chemistry	Class 1	862.1113	2016-11-25
JFP	Electrode, Ion Specific, Calcium	Clinical Chemistry	Class 2	862.1145	2016-11-25
CGZ	Electrode, Ion-Specific, Chloride	Clinical Chemistry	Class 2	862.1170	2016-11-25
KHP	Acid, Lactic, Enzymatic Method	Clinical Chemistry	Class 1	862.1450	2016-11-25
KQI	Assay, Fetal Hemoglobin	Hematology	Class 2	864.7455	2016-11-25
GHS	Assay, Carboxyhemoglobin	Hematology	Class 2	864.7425	2016-11-25
CIG	Diazo Colorimetry, Bilirubin	Clinical Chemistry	Class 2	862.1110	2016-11-25
JGS	Electrode, Ion Specific, Sodium	Clinical Chemistry	Class 2	862.1665	2016-11-25
CHL	Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph	Clinical Chemistry	Class 2	862.1120	2016-11-25
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2016-11-25
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
CEM	Electrode, Ion Specific, Potassium	Clinical Chemistry	Class 2	862.1600	2015-03-26
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2015-03-26
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2015-03-26
GKR	System, Hemoglobin, Automated	Hematology	Class 2	864.5620	2015-03-26
GHS	Assay, Carboxyhemoglobin	Hematology	Class 2	864.7425	2015-03-26
CHL	Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph	Clinical Chemistry	Class 2	862.1120	2015-03-26
KQI	Assay, Fetal Hemoglobin	Hematology	Class 2	864.7455	2015-03-26
JFP	Electrode, Ion Specific, Calcium	Clinical Chemistry	Class 2	862.1145	2015-03-26
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2015-03-26
JGS	Electrode, Ion Specific, Sodium	Clinical Chemistry	Class 2	862.1665	2015-03-26
KHP	Acid, Lactic, Enzymatic Method	Clinical Chemistry	Class 1	862.1450	2015-03-26
CGZ	Electrode, Ion-Specific, Chloride	Clinical Chemistry	Class 2	862.1170	2015-03-26
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2022-06-28
MQM	Bilirubin (Total And Unbound) In The Neonate Test System	Clinical Chemistry	Class 1	862.1113	2024-12-18
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2015-03-25

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
1523456	RADIOMETER AMERICA, INC.	Middleburg Heights, OH, US
3007490412	Radiometer Sp. z o.o	Stargard Zachodniopomorskie, PL

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K893133	Mennen Medical, Inc.	HORIZON 2110/HORIZON 2210 264-XXX-XXX/261-XXX-XXX	1989-07-14
K903523	Hewlett-Packard Co.	HP MODEL M1020A, ARTERIAL OXYGEN SAT/PLETH MODULE	1990-10-23
K973147	Nellcor Puritan Bennett, Inc.	NPB-295 PULSE OXIMETER	1997-11-14
K231243	Guangdong Genial Technology Co., Ltd.	Finger Clip Pulse Oximeter	2023-10-31
K971628	Somanetics Corp.	SOMANETICS INVOS 3100A CEREBRAL OXIMETER (INVOS)	1997-10-10

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0020-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20 (US) N, Part Number CS08651
Z-0022-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-02
Z-0023-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-03
Z-0028-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	Capnostream20 (US) M, Part Number CS08653
Z-0029-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	Capnostream20 (US) M W/PRINTER, Part Number CS08659

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013513377. Last updated year: 2026. Please use registration number 3013513377 when referencing this establishment in official correspondence.