FDA applicant

Eurotrol B.V.

Ede, NL7 decisions2006–20190 recalls

FDA records 7 decisions for Eurotrol B.V. (Ede, NL) from 2006 to 2019: 7 510(k) clearances. Most are in product codes GGM (Control, Hemoglobin) and JJY (Multi-Analyte Controls, All Kinds (Assayed)). Its devices cite 7 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, clinical chemistry panel, where it files most

How often FDA has decided Eurotrol B.V.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2019

2007high 2 (2013) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Eurotrol B.V. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Eurotrol B.V.

Which product codes does it file in?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?