Eurotrol B.V.
NL-MF-000005790 · Netherlands · Ede
Eurotrol B.V. is registered in the European database on medical devices as a manufacturer, with 40 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
Devices declared under this manufacturer
- CueSee HbA1c - Level 2
- CueSee HbA1c - Level 3
- Eurotrol epoc Calibration Verification Fluids
- Eurotrol epoc GAS-ISE Metabolites Level 3
- GlucoTrol Level 1
- GlucoTrol-NG Level 1
- GlucoTrol-NG Level 2
- GlucoTrol-NG Level 3
- Hb 301 Control High
- Hb 301 Control Low
- HemoTrol Duo Normal
- HemoTrol High (Level 3)
Showing 12 of 40 declared devices.
Catalogue references include 053.003.002, 146.002.002, 147.003.002, 155.003.002, 185.001.002, 202.001.002.
European nomenclature codes declared: W0101050299, W0103010504, W0101050101, W010106010801, W010106020601.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | EUROTROL B.V. (NL) · FDA 9681518 |
| Devices in EUDAMED | 40 |
| Country of registration | Netherlands |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | EUROTROL B.V. |
What it holds in Canada
| Licences on record | 7 |
|---|---|
| Currently active | 0 |
| Class 3 devices | 7 |
| First licensed | 2007-04-12 |
Licence types: Device Family (6), Single Device (1).
Licensed under: EUROTROL PLASMA/LOW HB CONTROL, EUROTROL HEMOTROL, EUROTROL ALBUTROL, EUROTROL HCT CONTROLS, GAS-ISE METABOLITES, EUROTROL EPOC CALIBRATION VERIFICATION FLUIDS.
North American profile: Both markets. Eurotrol B.V. is registered in both the United States and Canada.