Certificates of Registration
Certificate ISO 13485:2016 Quality Management System
EC Certificates
EC QMS Certificate MDR Class Ir and Is
EC QMS Certificate MDR Class IIa
EC QMS Certificate MDR Class III
EC Technical documentation assessment certification MDR Class III
Swedish Medical Products Agency
Confirmation of Registration Sweden
Product list (CE mark)
Clinical Microdialysis products |
MDR Class I (r), I (s) |
|
| REF | Description |
| P000055 | Tunnelating needle |
| P000056 | Forceps |
| 8010191106 | Pump Syringe |
MDR Class IIa |
|
| REF | Description |
| 8010226 | 61 Microdialysis Catheter, incl. SI-2 |
| 8050191 | 61 High Cut-Off 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 |
| P000034 | Perfusion fluid T1 |
| P000151 | Perfusion fluid CNS |
| 8050151 | Perfusion fluid CNS Dextran |
MDR 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 |
| Summary of safety and clinical performance (SSCP). | |
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 |
