Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in NetherlandsLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Eurotrol B.V. with 7 510(k) clearances and 2 device recalls. The most recent is a 510(k) clearance dated Nov 15, 2019: HemoTrol Duo Low, HemoTrol Duo Normal, HemoTrol Duo High.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Nov 15, 2019 | HemoTrol Duo Low, HemoTrol Duo Normal, HemoTrol Duo HighK192842 · GGM | 510(k) clearances |
| Feb 1, 2019 | HemoTrol WB - Low, HemoTrol WB - Normal, HemoTrol WB - HighK182744 · GGM | 510(k) clearances |
| Oct 18, 2018 | HemoTrol Level 3- In Vitro Diagnostic Hematology quality control mixture. Catalogue number: 171.003.002 Eurotrol HemoLin is an assayed hClass II · Incorrect measurement results caused by microbial contamination of the product, results in values lower than assigned va | Device recalls |
| Oct 18, 2018 | HemoTrol Level 2- In Vitro Diagnostic Hematology quality control mixture Catalogue number: 171.002.002 Eurotrol HemoLin is an assayed heClass II · Incorrect measurement results caused by microbial contamination of the product, results in values lower than assigned va | Device recalls |
| Apr 22, 2016 | CueSee HypoxicK152553 · JJS | 510(k) clearances |
| Jul 26, 2013 | EUROTROL GAS-ISE HCT QC AND EUROTROL GAS-ISE HCT LVMK131595 · JJY | 510(k) clearances |
| May 10, 2013 | EUROTROL HEMATOCRIT CONTROLK121467 · GLK | 510(k) clearances |
| Jun 22, 2012 | EUROTROL GAS-ISE METABOLITESK121468 · JJY | 510(k) clearances |
| Mar 24, 2006 | ALBU TROL, LOW, MODEL 108.001.002; ALBU TROL, HIGH 108.002.002K060215 · JJX | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
