M Dialysis Inc

FDA Filings

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

M Dialysis Inc holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

FDA Registration(s)
Registration Number3000157514
FEI Number3000157514
NameM DIALYSIS, INC.
Owner & OperatorM DIALYSIS AB
Contact AddressHammarby Fabriksvag 43 --
Stockholm SE-NOTA 120 30 SE
Registration Status1
Initial ImporterY
Registration Expiration2020-04-25
Registration Address73 PRINCETON ST. Suite 302
N Chelmsford, MA 01863 US



FDA Filings

Device
Company
DeviceDate
M DIALYSIS INC.
ISCUSflex 80032952019-10-07
M DIALYSIS INC.
L-P-G Reagent kit 80103612019-10-07
M DIALYSIS INC.
70 Microdialysis Bolt Catheter 130/10, 4/pkg P0001312019-10-07
M DIALYSIS INC.
70 Brain Microdialysis Catheter 60/10, 4/pkg P0000492019-10-07
M DIALYSIS INC.
70 Brain Microdialysis Catheter 100/10, 4/pkg P0000502019-10-07
M DIALYSIS INC.
Calibrator A P0000572019-10-07
M DIALYSIS INC.
Reagent Set C 80021652019-10-07
M DIALYSIS INC.
Reagent Set B 80021642019-10-07
M DIALYSIS INC.
Reagent Set A 80021632019-10-07
M DIALYSIS INC.
Reagent Kit P0000112019-10-07
M DIALYSIS INC.
106 Microdialysis Pump P0000032018-11-29
M DIALYSIS INC.
MD Pump Kit, Brain Tissue 80037912018-03-29
M DIALYSIS INC.
ICUpilot Software eng 80010272018-03-29
M DIALYSIS INC.
Control Samples US 80103062018-03-29
M DIALYSIS INC.
Glucose reagent P0000232018-03-29
M DIALYSIS INC.
Microvials in rack, Sterile 12x4 P0001542018-03-29
M DIALYSIS INC.
Rinsing Fluid 0.5 L 8/pkg 80021712018-03-29
M DIALYSIS INC.
Pyruvate reagent P0000632018-03-29
M DIALYSIS INC.
Lactate reagent P0000242018-03-29
M DIALYSIS INC.
Glycerol reagent P0000252018-03-29
M DIALYSIS INC.
Glutamate reagent P0000642018-03-29
M DIALYSIS INC.
Perfusion fluid CNS P0001512018-03-29
M DIALYSIS INC.
Microvials 250/pkg P0000012018-03-29
M DIALYSIS INC.
Microvial rack 12/pkg P0000282018-03-29
M DIALYSIS INC.
106 Syringe 80101912018-03-29
M DIALYSIS INC.
Battery 2x3V, 106 MD Pump 80017882018-03-29

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