Facility

EUROTROL B.V.

1 recall(s) on record — most severe on record: Class II.

Key facts

1recalls · worst Class II

1inspections · worst VAI

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3005695774
Establishment type	Manufacture Medical Device
Location	KEPLERLAAN 20 EDE Gelderland, NL 6716 BS
Registration status	Active · expires 2026
Parent company	EUROTROL B.V. (owner-operator 9023488)
Brand names	CueSee® Coag 2; CueSee® Coag 4; CueSee® Coag 1; CueSee® Coag 5; CueSee® Coag 3

Activity by year

Recalls (1)
Inspections (1)

Devices registered here (1)

Plasma, Coagulation Control
Product code GGN (opens in a new tab) · Class II · Hematology · 21 CFR 864.5425

Recalls & enforcement

Class IITerminated2018-10-18
Incorrect measurement results caused by microbial contamination of the product, results in values lower than assigned values

FDA inspections (1)

VAI2016-05-06
Voluntary Action Indicated · Compliance: Devices · citations posted

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

All facilities operated by EUROTROL B.V.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “EUROTROL B.V. (FEI 3005695774) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3005695774-eurotrol-b-v/

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