Bart Maas

FDA Filings

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

FDA Registration(s)
Registration Number9681518
FEI Number3005695774
NameBart Maas
Owner & OperatorEUROTROL B.V.
Contact AddressKEPLERLAAN 20 --
EDE NL-GE Gelderland NL 6716 BS NL
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address850 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
DeviceDate
Bart Maas [EUROTROL B.V.]
HemoTrol Duo Normal2019-12-13
Bart Maas [EUROTROL B.V.]
HemoTrol Duo Low2019-12-13
Bart Maas [EUROTROL B.V.]
HemoTrol Duo High2019-12-13
Bart Maas [EUROTROL B.V.]
Hemotrol WB - Normal2019-03-14
Bart Maas [EUROTROL B.V.]
Hemotrol WB - Low2019-03-14
Bart Maas [EUROTROL B.V.]
Hemotrol WB - High2019-03-14
Bart Maas [EUROTROL B.V.]
CueSee Hypoxic2016-04-28
Bart Maas [EUROTROL B.V.]
CueSee? VeriSTAT QC, Level 3 - 221.003.0102013-07-29
Bart Maas [EUROTROL B.V.]
CueSee? VeriSTAT QC, Level 2 - 221.002.0102013-07-29
Bart Maas [EUROTROL B.V.]
CueSee? VeriSTAT QC, Level 1 - 221.001.0102013-07-29
Bart Maas [EUROTROL B.V.]
CueSee? VeriSTAT LVM - 220.000.0052013-07-29
Bart Maas [EUROTROL B.V.]
epoc Hematocrit Verification Fluids - 190.000.0052013-05-24
Bart Maas [EUROTROL B.V.]
Eurotrol Hct Control, Level C - 195.003.0102013-05-24
Bart Maas [EUROTROL B.V.]
Eurotrol Hct Control, Level B - 195.004.0102013-05-24
Bart Maas [EUROTROL B.V.]
Eurotrol Hct Control, Level A - 195.002.0102013-05-24
Bart Maas [EUROTROL B.V.]
Eurotrol Hb301 Control - Level 3 - 188.003.0022012-07-19
Bart Maas [EUROTROL B.V.]
Eurotrol Hb301 Control - Level 2 - 188.002.0022012-07-19
Bart Maas [EUROTROL B.V.]
Eurotrol Hb301 Control - Level 1 - 188.001.0022012-07-19
Bart Maas [EUROTROL B.V.]
Eurotrol? epoc? Calibration Verification Fluids - 267.000.0052012-07-17
Bart Maas [EUROTROL B.V.]
Eurotrol epoc GAS-ISE Metabolites ? Level 6 - 266.006.0102012-07-17
Bart Maas [EUROTROL B.V.]
Eurotrol epoc GAS-ISE Metabolites ? Level 3 - 266.003.0102012-07-17
Bart Maas [EUROTROL B.V.]
Eurotrol epoc GAS-ISE Metabolites ? Level 2 - 266.002.0102012-07-17
Bart Maas [EUROTROL B.V.]
Eurotrol epoc GAS-ISE Metabolites ? Level 1 - 266.001.0102012-07-17
Bart Maas [EUROTROL B.V.]
Eurotrol GAS-ISE Metabolites - Level 3 - 179.003.0102012-07-17
Bart Maas [EUROTROL B.V.]
Eurotrol GAS-ISE Metabolites - Level 2 - 179.002.0102012-07-17
Bart Maas [EUROTROL B.V.]
Eurotrol GAS-ISE Metabolites - Level 1 - 179.001.0102012-07-17
Bart Maas [EUROTROL B.V.]
EPOC Calibration Verification Fluids - 183.000.0052012-07-17
Bart Maas [EUROTROL B.V.]
Glucotrol-NG, Level 4 - 170.004.0022008-02-28
Bart Maas [EUROTROL B.V.]
Glucotrol-NG, Level 3 - 170.003.0022008-02-28
Bart Maas [EUROTROL B.V.]
Glucotrol-NG, Level 2 - 170.002.0022008-02-28
Bart Maas [EUROTROL B.V.]
GlucoTrol-AQ - 180.013.0022008-02-28
Bart Maas [EUROTROL B.V.]
HemoTrol, Level 3 - 171.003.0022008-02-28
Bart Maas [EUROTROL B.V.]
HemoTrol, Level 2 - 171.002.0022008-02-28
Bart Maas [EUROTROL B.V.]
HemoTrol, Level 1 - 171.001.0022008-02-28
Bart Maas [EUROTROL B.V.]
GlucoLin - 025.000.0052008-02-28
Bart Maas [EUROTROL B.V.]
HYPERBARIC QC - 164.002.0042008-02-28
Bart Maas [EUROTROL B.V.]
AlbuTrol, Level 2 - 189.002.0021996-10-11
Bart Maas [EUROTROL B.V.]
AlbuTrol, Level 1 - 189.001.0021996-10-11

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