Product Certificates

Certificate for the ISO13485:2003 quality standard 

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Certificate of Registration for CE mark

• ISCUS CLINICAL MICRODIALYSIS ANALYZER
• ISCUSflex MICRODIALYSIS ANALYZER
• CMA 600 MICRODIALYSIS ANALYSER
• REAGENTS
  Glucose
  Lactate
  Pyruvate,
  Glutamate
  Glycerol
  Urea
  L-P-G Reagent Kit
  Reagent Kit
  Reagent sets A, B and C
  Calibrator A
• ACCESSORIES
  Microvials
  Microvials in Rack, sterile
  Rinsing Fluid 8x1L and 8x0.5L
  Control Samples
  Tunnelating Needle
  Forceps
• SOFTWARE
  ICUpilot Software
   
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  NOTE! One certificate handles all products above download PDF fil

EC Certificate for

• CMA 60 Serie MICRODIALYSIS CATHETERS & INTRODUCERS (including CMA 61, 62, 63, IView 64 and 66) 
• MICRODIALYSIS PUMPS
• SYRINGES, PERFUSION FLUID

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  NOTE! One certificate handles all products above download PDF file

• MICROVIALS in Rack, sterile
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• CMA 70/71 MICRODIALYSIS CATHETERS
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Statement of Conformity:

• CMA 600 MICRODIALYSIS ANALYSER
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• ISCUS CLINICAL MICRODIALYSIS ANALYZER
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510(k) clearance

(for your help: applicant name = CMA) 
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