HomeNetherlandsEurotrol B.V.

Eurotrol B.V.

Netherlands · Ede · eurotrol.com
✓ Record-verifiedregistrations found in 9 marketsEU SRN NL-MF-000005790

This company has registrations in European Union, United States, United Kingdom, Brazil, Canada, Taiwan, Hong Kong, Israel, Russia — 9 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
n/aThis registry lists domestic registrants only
EUEuropean UnionEUDAMED
40UDI-DI device records
IVD general 40
USUnited StatesFDA openFDA
8listed device types
Class I 4Class II 4Class III 0
plus 17 registration records and 7 510(k)
UKUnited KingdomMHRA PARD
4registered device records
IVD general 4
BRBrazilANVISA
5registered devices
Class II 5
6 including historic records
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
2active device licences
Class III 2
9 including historic records
TWTaiwanTFDA
2valid device licences
Class I 2
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
2valid listings
IVD B 2
ILIsraelAMAR
1registrations
RURussiaRoszdravnadzor
5active registrations
Class 2a 4Class 2b 1
Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

European Union40 raw hits, 0 excluded, 40 confirmed
United States17 registration records, 7 510(k), 0 PMA
United Kingdom4 confirmed, 0 excluded
Brazil5 confirmed, 0 excluded
Canada2 confirmed, 0 excluded
Manufacturer names merged into this page: EUROTROL B.V.

Regulatory identity

EU manufacturer SRN
NL-MF-000005790
UK responsible person
Qserve Group UK, Ltd.

Company information

Country
Netherlands
City
Ede
Website
eurotrol.com
Product categories
Clinical Diagnostics & Therapeutic TechnologiesLaboratory, IVD & DiagnosticsClinical chemistry & immunoassaysHematology & coagulationPoint-of-care & near-patient testing

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

Business registration

LEI
724500TOML6RWLOANF32
Registration status
Active
Legal form
besloten vennootschap met beperkte aansprakelijkheid (BV)
Incorporated
1988-06-14
Registered address
Keplerlaan 20, Ede, 6716BS
Registration authority
Business Register, no. 09067367
Registry record updated
2026-02-17

Business registration data from GLEIF, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.

FDA 510(k) clearances by year

12006 · K060215
12012 · K121468
22013 · K131595
12016 · K152553
22019 · K192842

FDA listed device types

Instrument, Hematocrit, Automated 1Plasma, Coagulation Control 1Control, Hematocrit 1Control, Hemoglobin 1Controls For Blood-Gases, (Assayed And Unassayed) 1Single (Specified) Analyte Controls (Assayed And Unassayed) 1Multi-Analyte Controls, All Kinds (Assayed) 1Multi-Analyte Controls Unassayed 1

Registration details (sample)

MarketIdentifierNameClass / date
EUD-AN01637A032AHemoTrol Duo HighIVD general
EUD-AN01637A0228HemoTrol Duo NormalIVD general
EUD-AN01637A0126HemoTrol Duo LowIVD general
EUD-202.003.00265HemoTrol High (Level 3)IVD general
UK37721Eurotrol AlbuTrol HighIVD general
UK41819Eurotrol GlucoTrol-NG level 1IVD general
UK52860epoc Hemotocrit Verification FluidsIVD general
USK192842HemoTrol Duo Low, HemoTrol Duo Normal, HemoTrol Duo High2019-11-15
USK182744HemoTrol WB - Low, HemoTrol WB - Normal, HemoTrol WB - High2019-02-01
USK152553CueSee Hypoxic2016-04-22
BR10033120988Família de Controles AlbuTrolClass II
BR10033120989Família de Controles GlucoTrol-NGClass II
BR10033120986Família de Controles HemoTrolClass II
CA73766EUROTROL DONOR HB CHECKER CONTROLClass III
CA84290EUROTROL HB 301 CONTROLClass III

Similar companies

Dutch Diagnostics B.V.
Netherlands · markets 2
PalmSens BV
Netherlands · markets 0
Agappe Diagnostics Switzerland GmbH
Switzerland · markets 2
Alifax S.r.l.
Italy · markets 10
Analyticon Biotechnologies GmbH
Germany · markets 8
Behnk Elektronik GmbH & Co. KG
Germany · markets 5
Is this your company? Claim the page, add information or report a data error.Claim / report an error →