Data / Medical devices / Netherlands / Eurotrol B.V.
Eurotrol B.V.: FDA-registered device maker in EDE Gelderland, Netherlands, 11 510(k) clearances
Eurotrol B.V. is registered with the FDA (registration 9681518) in EDE Gelderland, Netherlands. It lists 8 device types. The FDA files 11 510(k) clearances under its listings, the newest dated November 15, 2019. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9681518
- FEI number
- 3005695774
- Address
- Keplerlaan 20, EDE Gelderland, Netherlands, 6716 BS
- Owner or operator
- EUROTROL B.V. (9023488)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- October 11, 1996
- Registered through
- 2026
- Brand names listed
- AlbuTrol, Level 1 - 1890102, AlbuTrol, Level 2 - 1890202, CueSee Hypoxic, CueSee VeriSTAT® LV, CueSee VeriSTAT® S1, CueSee VeriSTAT® S2, CueSee VeriSTAT® S3, CueSee® BGEM 1 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Control, Hematocrit | GLK | 2 | Manufacturer | accessdata.fda.gov |
| Control, Hemoglobin | GGM | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Controls For Blood-Gases, (Assayed And Unassayed) | JJS | 1 | Manufacturer | accessdata.fda.gov |
| Instrument, Hematocrit, Automated | GKF | 2 | Contract manufacturer | accessdata.fda.gov |
| Multi-Analyte Controls Unassayed | OHQ | 1 | Manufacturer | accessdata.fda.gov |
| Multi-Analyte Controls, All Kinds (Assayed) | JJY | 1 | Manufacturer | accessdata.fda.gov |
| Plasma, Coagulation Control | GGN | 2 | Manufacturer | accessdata.fda.gov |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 15, 2019 | K192842 | HemoTrol Duo Low, HemoTrol Duo Normal, HemoTrol Duo High | GGM | Substantially Equivalent | Eurotrol B.V. | accessdata.fda.gov |
| April 22, 2016 | K152553 | CueSee Hypoxic | JJS | Substantially Equivalent | Eurotrol B.V. | accessdata.fda.gov |
| July 26, 2013 | K131595 | EUROTROL GAS-ISE HCT QC AND EUROTROL GAS-ISE HCT LVM | JJY | Substantially Equivalent | Eurotrol B.V. | accessdata.fda.gov |
| May 10, 2013 | K121467 | EUROTROL HEMATOCRIT CONTROL | GLK | Substantially Equivalent | Eurotrol B.V. | accessdata.fda.gov |
| June 22, 2012 | K121468 | EUROTROL GAS-ISE METABOLITES | JJY | Substantially Equivalent | Eurotrol B.V. | accessdata.fda.gov |
| March 24, 2006 | K060215 | ALBU TROL, LOW, MODEL 108.001.002; ALBU TROL, HIGH 108.002.002 | JJX | Substantially Equivalent | Eurotrol B.V. | accessdata.fda.gov |
| November 8, 1996 | K963909 | HEMOCUE GLUCOLIN | JJX | Substantially Equivalent | Direct Solutions | accessdata.fda.gov |
| November 6, 1996 | K964052 | HEMOCUE HEMOTROL | GGM | Substantially Equivalent | Direct Solutions | accessdata.fda.gov |
| November 1, 1996 | K964053 | HEMOCUE GLUCOTROL | JJX | Substantially Equivalent | Direct Solutions | accessdata.fda.gov |
| October 16, 1996 | K963908 | HEMOCUE HEMOLIN | GGM | Substantially Equivalent | Direct Solutions | accessdata.fda.gov |
| December 26, 1995 | K955340 | EUROTROL GAS - ISE CONTROL | JJS | Substantially Equivalent | Direct Solutions | accessdata.fda.gov |
Compare with other makers
- All makers of Control, Hemoglobin
- All makers of Multi-Analyte Controls, All Kinds (Assayed)
- All makers of Controls For Blood-Gases, (Assayed And Unassayed)
- All makers of Instrument, Hematocrit, Automated
- All makers of Control, Hematocrit
- All makers of Single (Specified) Analyte Controls (Assayed And Unassayed)
Updated November 15, 2019. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.