Eurotrol B V

FDA Filings

This page includes the latest FDA filings for Eurotrol B V. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 9681518
• FEI Number: 3005695774
• Name: Bart Maas
• Owner & Operator: EUROTROL B.V.
• Contact Address: KEPLERLAAN 20 --; EDE NL-GE Gelderland NL 6716 BS NL
• US Agent:
  • Bart Maas
  • EUROTROL INC.
  • 502 5011180
  • bmaas@eurotrol.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 850 N Black Branch Rd ; Elizabethtown, KY 42701 US
• Establishment Type:
  • Manufacture Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device Company	Device	Date
GUDID 08718734962656 Eurotrol B.V.	CueSee® CO-OX AN01718A07	2025-01-31
GUDID 08718734960539 Eurotrol B.V.	Eurotrol 250.003.002	2025-01-28
GUDID 08718734960515 Eurotrol B.V.	Eurotrol 250.002.002	2025-01-28
GUDID 08718734960492 Eurotrol B.V.	Eurotrol 250.001.002	2025-01-28
GUDID 08718734962632 Eurotrol B.V.	CueSee VeriSTAT® AN01902A04	2024-11-06
GUDID 08718734962625 Eurotrol B.V.	CueSee VeriSTAT® AN01902A03	2024-11-06
GUDID 08718734962618 Eurotrol B.V.	CueSee VeriSTAT® AN01902A02	2024-11-06
GUDID 08718734962526 Eurotrol B.V.	CueSee VeriSTAT® AN01902A01	2024-11-06
GUDID 08718734960973 Eurotrol B.V.	HemoTrol WB 08718734960942	2024-08-29
GUDID 08718734960966 Eurotrol B.V.	HemoTrol WB 08718734960966	2024-08-29
GUDID 08718734960959 Eurotrol B.V.	HemoTrol WB 08718734960959	2024-08-29
GUDID 08718734960928 Eurotrol B.V.	Eurotrol	2022-09-16
GUDID 08718734960904 Eurotrol B.V.	Eurotrol	2022-09-16
GUDID 08718734960881 Eurotrol B.V.	Eurotrol	2022-09-16
GUDID 08718734960867 Eurotrol B.V.	Eurotrol	2022-09-16
GUDID 08718734962403 Eurotrol B.V.	CueSee® CO-OX AN01718A06	2021-12-27
GUDID 08718734962397 Eurotrol B.V.	CueSee® CO-OX AN01718A05	2021-12-27
GUDID 08718734961635 Eurotrol B.V.	CueSee® CO-OX AN01718A04	2021-12-27
GUDID 08718734961628 Eurotrol B.V.	CueSee® CO-OX AN01718A03	2021-12-27
GUDID 08718734961611 Eurotrol B.V.	CueSee® CO-OX AN01718A02	2021-12-27
GUDID 08718734961604 Eurotrol B.V.	CueSee® CO-OX AN01718A01	2021-12-27
GUDID 08718734961086 Eurotrol B.V.	CueSee® CO-OX AN01486A04	2021-12-27
GUDID 08718734961079 Eurotrol B.V.	CueSee® CO-OX AN01486A03	2021-12-27
GUDID 08718734961062 Eurotrol B.V.	CueSee® CO-OX AN01486A03	2021-12-27
GUDID 08718734961000 Eurotrol B.V.	CueSee® CO-OX AN01486A01	2021-12-27
GUDID 08718734961109 Eurotrol B.V.	CueSee® Hyperbaric X-High 164.002.004	2021-06-16
GUDID 08718734961529 Eurotrol B.V.	CueSee® VeriSTAT QC 221.003.010	2020-10-16
GUDID 08718734961512 Eurotrol B.V.	CueSee® VeriSTAT QC 221.002.010	2020-10-16
GUDID 08718734961505 Eurotrol B.V.	CueSee® VeriSTAT QC 221.001.010	2020-10-16
GUDID 08718734961468 Eurotrol B.V.	CueSee® VeriSTAT LVM	2020-10-16
GUDID 08718734961406 Eurotrol B.V.	GlucoLin	2020-10-16
GUDID 08718734960935 Eurotrol B.V.	Eurotrol GlucoTrol-AQ	2020-10-16
GUDID 08718734960669 Eurotrol B.V.	CueSee® Hypoxic 166.001.005	2020-10-16
GUDID 08718734960638 Eurotrol B.V.	Eurotrol AlbuTrol 189.002.002	2020-10-16
GUDID 08718734960614 Eurotrol B.V.	Eurotrol AlbuTrol 189.001.002	2020-10-16
GUDID 08718734960591 Eurotrol B.V.	Eurotrol GlucoTrol-NG 170.004.002	2020-10-16
GUDID 08718734960577 Eurotrol B.V.	Eurotrol GlucoTrol-NG 170.003.002	2020-10-16
GUDID 08718734960560 Eurotrol B.V.	Eurotrol GlucoTrol-NG 170.002.002	2020-10-16
PMN K192842 | GGM Bart Maas [EUROTROL B.V.]	HemoTrol Duo Normal	2019-12-13
PMN K192842 | GGM Bart Maas [EUROTROL B.V.]	HemoTrol Duo Low	2019-12-13
PMN K192842 | GGM Bart Maas [EUROTROL B.V.]	HemoTrol Duo High	2019-12-13
PMN K192842 Eurotrol B.V.	HemoTrol Duo Low, HemoTrol Duo Normal, HemoTrol Duo High	2019-11-15
PMN K182744 | GGM Bart Maas [EUROTROL B.V.]	Hemotrol WB - Normal	2019-03-14
PMN K182744 | GGM Bart Maas [EUROTROL B.V.]	Hemotrol WB - Low	2019-03-14
PMN K182744 | GGM Bart Maas [EUROTROL B.V.]	Hemotrol WB - High	2019-03-14
PMN K182744 EUROTROL B.V.	HemoTrol WB - Low, HemoTrol WB - Normal, HemoTrol WB - High	2019-02-01
PMN K152553 | JJS Bart Maas [EUROTROL B.V.]	CueSee Hypoxic	2016-04-28
PMN K152553 EUROTROL B.V.	CueSee Hypoxic	2016-04-22
PMN K131595 | JJY Bart Maas [EUROTROL B.V.]	CueSee? VeriSTAT QC, Level 3 - 221.003.010	2013-07-29
PMN K131595 | JJY Bart Maas [EUROTROL B.V.]	CueSee? VeriSTAT QC, Level 2 - 221.002.010	2013-07-29
PMN K131595 | JJY Bart Maas [EUROTROL B.V.]	CueSee? VeriSTAT QC, Level 1 - 221.001.010	2013-07-29
PMN K131595 | JJY Bart Maas [EUROTROL B.V.]	CueSee? VeriSTAT LVM - 220.000.005	2013-07-29
PMN K131595 EUROTROL B.V.	EUROTROL GAS-ISE HCT QC AND EUROTROL GAS-ISE HCT LVM	2013-07-26
PMN K121467 | GLK Bart Maas [EUROTROL B.V.]	epoc Hematocrit Verification Fluids - 190.000.005	2013-05-24
PMN K121467 | GLK Bart Maas [EUROTROL B.V.]	Eurotrol Hct Control, Level C - 195.003.010	2013-05-24
PMN K121467 | GLK Bart Maas [EUROTROL B.V.]	Eurotrol Hct Control, Level B - 195.004.010	2013-05-24
PMN K121467 | GLK Bart Maas [EUROTROL B.V.]	Eurotrol Hct Control, Level A - 195.002.010	2013-05-24
PMN K121467 EUROTROL B.V.	EUROTROL HEMATOCRIT CONTROL	2013-05-10
PMN BK030067 | GGM Bart Maas [EUROTROL B.V.]	Eurotrol Hb301 Control - Level 3 - 188.003.002	2012-07-19
PMN BK030067 | GGM Bart Maas [EUROTROL B.V.]	Eurotrol Hb301 Control - Level 2 - 188.002.002	2012-07-19
PMN BK030067 | GGM Bart Maas [EUROTROL B.V.]	Eurotrol Hb301 Control - Level 1 - 188.001.002	2012-07-19
PMN K121468 | JJY Bart Maas [EUROTROL B.V.]	Eurotrol? epoc? Calibration Verification Fluids - 267.000.005	2012-07-17
PMN K121468 | JJY Bart Maas [EUROTROL B.V.]	Eurotrol epoc GAS-ISE Metabolites ? Level 6 - 266.006.010	2012-07-17
PMN K121468 | JJY Bart Maas [EUROTROL B.V.]	Eurotrol epoc GAS-ISE Metabolites ? Level 3 - 266.003.010	2012-07-17
PMN K121468 | JJY Bart Maas [EUROTROL B.V.]	Eurotrol epoc GAS-ISE Metabolites ? Level 2 - 266.002.010	2012-07-17
PMN K121468 | JJY Bart Maas [EUROTROL B.V.]	Eurotrol epoc GAS-ISE Metabolites ? Level 1 - 266.001.010	2012-07-17
PMN K121468 | JJY Bart Maas [EUROTROL B.V.]	Eurotrol GAS-ISE Metabolites - Level 3 - 179.003.010	2012-07-17
PMN K121468 | JJY Bart Maas [EUROTROL B.V.]	Eurotrol GAS-ISE Metabolites - Level 2 - 179.002.010	2012-07-17
PMN K121468 | JJY Bart Maas [EUROTROL B.V.]	Eurotrol GAS-ISE Metabolites - Level 1 - 179.001.010	2012-07-17
PMN K121468 | JJY Bart Maas [EUROTROL B.V.]	EPOC Calibration Verification Fluids - 183.000.005	2012-07-17
PMN K121468 EUROTROL B.V.	EUROTROL GAS-ISE METABOLITES	2012-06-22
PMN K964053 | JJX Bart Maas [EUROTROL B.V.]	Glucotrol-NG, Level 4 - 170.004.002	2008-02-28
PMN K964053 | JJX Bart Maas [EUROTROL B.V.]	Glucotrol-NG, Level 3 - 170.003.002	2008-02-28
PMN K964053 | JJX Bart Maas [EUROTROL B.V.]	Glucotrol-NG, Level 2 - 170.002.002	2008-02-28
PMN K964053 | JJX Bart Maas [EUROTROL B.V.]	GlucoTrol-AQ - 180.013.002	2008-02-28
PMN K964052 | GGM Bart Maas [EUROTROL B.V.]	HemoTrol, Level 3 - 171.003.002	2008-02-28
PMN K964052 | GGM Bart Maas [EUROTROL B.V.]	HemoTrol, Level 2 - 171.002.002	2008-02-28
PMN K964052 | GGM Bart Maas [EUROTROL B.V.]	HemoTrol, Level 1 - 171.001.002	2008-02-28
PMN K963909 | JJX Bart Maas [EUROTROL B.V.]	GlucoLin - 025.000.005	2008-02-28
PMN K955340 | JJS Bart Maas [EUROTROL B.V.]	HYPERBARIC QC - 164.002.004	2008-02-28
PMN K060215 EUROTROL B.V.	ALBU TROL, LOW, MODEL 108.001.002; ALBU TROL, HIGH 108.002.002	2006-03-24
PMN K060215 | JJX Bart Maas [EUROTROL B.V.]	AlbuTrol, Level 2 - 189.002.002	1996-10-11
PMN K060215 | JJX Bart Maas [EUROTROL B.V.]	AlbuTrol, Level 1 - 189.001.002	1996-10-11

Related Finance Registrations

NCAGE Code	H1V07	EUROTROL B.V.
CAGE Code	H1V07	EUROTROL B.V.

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020091248129	Rotterdam,Netherlands -> Miami, Florida	FURNITURE, BEDS AND ACCESSORIES	145 PKG
2019102554324	Rotterdam,Netherlands -> Miami, Florida	FREIGHT PREPAID PARTS ACCESSORIES FOR KITCHEN PACKED AS ON 10 PALLETS + 6 PIECES HS CODE: 9403.40.00 6910.90.00 7323.99.90 9403.60.00 7013.99.00 6910.10.00 3922.20.0 940340 (HS)	70 PCS