Certificates of Registration

Certificate ISO 13485:2016 Quality Management System

Certificate ISO 13485:2016

EC Certificates

EC QMS Certificate MD Class III

EC QMS Certificate MD Class II

EC Design Examination Certificate MD Class III

Swedish Medical Products Agency

Confirmation of Registration Sweden

Product list (CE mark)

Clinical Microdialysis products

MD Class I

REF Description
P000055 Tunnelating needle
P000056 Forceps
P000157 LABpilot™ Software
8001027 ICUpilot Software, eng

MD Class II

REF Description
8010226 61 Hepatic Microdialysis Catheter, incl. SI-2
8050191 61 High Cut Off Microdialysis Catheter
8010292 62 GI Microdialysis Catheter
8010509 63 Microdialysis Catheter, 60/10, incl. SI-2
8010514 63 Microdialysis Catheter, 40/30, incl. SI-2
8010650 66 Linear Cath, 30mm 20kD, incl. Introd.
8010651 66 Linear Cath, 30mm 100kD, incl. Introd.
8010670 66 Linear Cath, 10mm 20kD, incl. Introd.
8010671 66 Linear Cath, 10mm 100kD, incl. Introd.
8050090 67 IV MD Catheter 46/10 incl. Introd.
8050091 67 IV MD Catheter 46/20 incl. Introd.
8050092 67 IV MD Catheter 46/30 incl. Introd.
8050093 67 IV MD Catheter 130/10 incl. Introd.
8010343 Splitable Introducer SI-2
P000003 106 Microdialysis Pump
P000127 107 Microdialysis Pump
8010191 106 Pump  Syringe
P000034 Perfusion fluid T1
P000151 Perfusion fluid CNS
8050151 Perfusion fluid CNS Dextran
MD System 1.0 and accessories

MD Class III

REF Description
P000131 70 MD Bolt Catheter, 130/10
P000049 70 Brain MD Catheter, 60/10
P000080 70 Brain MD Catheter, 60/20
P000081 70 Brain MD Catheter, 60/30
P000050 70 Brain MD Catheter, 100/10
P000051 70 Brain MD Catheter, 90/20
P000052 70 Brain MD Catheter, 80/30
8010320 71 High Cut-Off Brain MD Catheter, 60/10
8010331 71 High Cut-Off Brain MD Catheter, 60/20
8010337 71 High Cut-Off Brain MD Catheter, 60/30
8010954 71 High Cut-Off  MD Bolt Catheter, 130/10

IVD

REF Description
P000001 Microvials
P000028 Microvial rack
P000154 Microvials in rack, Sterile
8003295 ISCUSflex Microdialysis Analyzer
P000023 Reagent Glucose
P000024 Reagent Lactate
P000063 Reagent Pyruvate
P000025 Reagent Glycerol
P000064 Reagent Glutamate
P000026 Reagent Urea
P000057 Calibrator A
8010201 Control Samples
8002171 Rinsing Fluid for Analyzer