Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9681518

FEI Number

3005695774

Entity Name

EUROTROL B.V.

City/State/Country

EDE Gelderland, NL

Establishment Address

KEPLERLAAN 20, EDE Gelderland 6716 BS, NL

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

EUROTROL B.V. (Owner Number: 9023488)

Owner / Operator Contact Address

KEPLERLAAN 20, --, EDE, NL-GE NL 6716 BS, NL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K192842

PMA Number

N/A

All Registered Proprietary Names

AlbuTrol, Level 2 - 1890202 AlbuTrol, Level 1 - 1890102 HemoTrol, Level 3 - 1710302 HemoTrol, Level 1 - 1710102 HemoTrol, Level 2 - 1710202 CueSee Hypoxic HYPERBARIC QC - 1640204 CueSee® Coag 3 CueSee® Coag 1 CueSee® Coag 4 CueSee® Coag 5 CueSee® Coag 2 Glucotrol-NG, Level 3 - 1700302 GlucoTrol-AQ - 1801302 Glucotrol-NG, Level 4 - 1700402 Glucotrol-NG, Level 2 - 1700202 Eurotrol epoc GAS-ISE Metabolites Level 2 - 2660210 Eurotrol epoc GAS-ISE Metabolites Level 3 - 2660310 Eurotrol epoc GAS-ISE Metabolites Level 1 - 2660110 Eurotrol epoc GAS-ISE Metabolites Level 6 - 2660610 Eurotrol® epoc® Calibration Verification Fluids - 2670005 GlucoLin - 0250005 Eurotrol Hb301 Control - Level 1 - 1880102 Eurotrol Hb301 Control - Level 2 - 1880202 Eurotrol Hb301 Control - Level 3 - 1880302 Eurotrol Hct Control, Level A - 1950210 Eurotrol Hct Control, Level C - 1950310 Eurotrol Hct Control, Level B - 1950410 epoc Hematocrit Verification Fluids - 1900005 CueSee® VeriSTAT QC, Level 3 - 2210310 CueSee® VeriSTAT QC, Level 1 - 2210110 CueSee® VeriSTAT LVM - 2200005 CueSee® VeriSTAT QC, Level 2 - 2210210 CueSee® Hyperbaric CSR 1 CueSee VeriSTAT® S2 CueSee VeriSTAT® S3 CueSee® BGEM 1 2 3 4 5 CueSee VeriSTAT® S1 CueSee VeriSTAT® LV CueSee® BGEM 3 CueSee® BGEM 2 CueSee® BGEM 1 HemoTrol Duo High HemoTrol Duo Low HemoTrol Duo Normal

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	1996-10-11
GGM	Control, Hemoglobin	Hematology	Class 2	864.8625	2008-02-28
GGM	Control, Hemoglobin	Hematology	Class 2	864.8625	2008-02-28
JJS	Controls For Blood-Gases, (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2016-04-28
JJS	Controls For Blood-Gases, (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2008-02-28
GGN	Plasma, Coagulation Control	Hematology	Class 2	864.5425	2025-04-07
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2008-02-28
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2012-07-17
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2008-02-28
GGM	Control, Hemoglobin	Hematology	Class 2	864.8625	2012-07-19
GLK	Control, Hematocrit	Hematology	Class 2	864.8625	2013-05-24
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2013-07-29
GKF	Instrument, Hematocrit, Automated	Hematology	Class 2	864.5600	2018-03-26
JJS	Controls For Blood-Gases, (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2025-12-01
OHQ	Multi-Analyte Controls Unassayed	Clinical Chemistry	Class 1	862.1660	2024-10-21
GGM	Control, Hemoglobin	Hematology	Class 2	864.8625	2019-12-13

Official Correspondent

No official correspondent registered.

US Agent Details

Bart Maas Business: EUROTROL INC. Email: bmaas@eurotrol.com Phone: (502) 5011180

Related Public Records

Same Entity

EUROTROL B.V.

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
K103744	Quantimetrix Corp.	DROPPER A1C DIABETES CONTROL	2011-05-12
K981281	Roche Diagnostics GmbH	ELECSYS CALCHECK FERRITIN	1998-04-24
K981278	Roche Diagnostics GmbH	ELECSYS CALCHECK CA 125II	1998-04-23
K143687	Siemens Healthcare Diagnostics, Inc.	ADVIA Centaur Follicle Stimulating Hormone (FSH) Master Curve Material, ADVIA Centaur FT4 Master Curve Material, ADVIA Centaur T4 Master Curve Material, ADVIA Centaur T3 Master Curve Material	2015-07-17
K143376	Siemens Healthcare Diagnostics, Inc.	ADIVA Centaur Progesterone Master Curve Material (MCM), ADIVA Centaur Ferritin Master Curve Material	2014-12-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0007-2008	Tosoh Bioscience Inc	1	4 glass vials per box. 2/4ml vials of Sample Diluting Solution & 2/2ml vials of Calibration Verification Material. BetaHCG Calibration Verification Test Set, in vitro diagnostic.
Z-0514-2014	Instrumentation Laboratory Co.	2	HemosIL Normal Control 1 UNASSAYED Part Number: 0020003120
Z-0515-2014	Instrumentation Laboratory Co.	2	HemosIL Low Abnormal Control 2 UNASSAYED Part Number: 0020003220
Z-0516-2014	Instrumentation Laboratory Co.	2	HemosIL High Abnormal Control 3 UNASSAYED Part Number: 0020003320

Similar Registrations

Registration Number	Establishment Name	Location
3007652384	MICROBIX	Mississauga Ontario, CA
3014353121	VIDAN DIAGNOSTICS, LLC	San Antonio, TX, US
3008514395	Telcare, LLC	Linwood, PA, US
3012118659	ASCENSIA DIABETES CARE HOLDINGS AG	Basel Basel-Stadt, CH
1319681	ORTHO-CLINICAL DIAGNOSTICS, INC.	Rochester, NY, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9681518. Last updated year: 2026. Please use registration number 9681518 when referencing this establishment in official correspondence.