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Regulatory Compliance

Approvals© scanrail/iStock

 

 

Quality Management System

CNSystems is certified according to EN ISO 13485, ISO 13485:2016 MDSAP Audit Model Edition 2 and PAL/Japan.

EN ISO 13485:2016+AC2016
Size: 235.66 KB Format: PDF

EN ISO 13485:2016 MDSAP Audit Model Ed 2
Size: 987.24 KB Format: PDF

Japanese PAL Certificate
Size: 349.61 KB Format: PDF


 

CE mark - notified body 0483

Notified Body

CNSystems' products are manufactured according to the 93/42/EEC directive and is yearly audited through:

mdc medical device certification GmbH

mdc - medical device certification© mdc

Kriegerstraße 6

D-70191 Stuttgart / Germany

Tel.: +49 (0)711 253597-0

Fax: +43 (0)711 253597-10

Email : This email address is being protected from spambots. You need JavaScript enabled to view it.

Website: www.mdc-ce.de

 


 

 

Certifications/ Approvals

EUROPE

CE-Certification according to directive 93/42/EEC, Annex II

FQAS acc. 93/42/EEC annex II
Size: 232.62 KB Format: PDF

Declarations of Conformity:

CE Declaration of Conformity for CNAP® Monitor
Size: 706.43 KB Format: PDF

 

USA

FDA-Certification according to 510(k) Clearance

FDA Clearance Letter for Task Force® Monitor
Size: 117.43 KB Format: PDF

FDA Clearance Letter for CNAP® Monitor
Size: 279.56 KB Format: PDF

 

Certification according to UL 60601-1:2003

NRTL Certificate for Task Force® Monitor
Size: 527.25 KB Format: PDF

NRTL Certificate for CNAP® Monitor
Size: 561.55 KB Format: PDF

 

CANADA

Certification according to CAN/CSA C22.2 No.601.1-M90

NRTL Certificate for Task Force® Monitor
Size: 527.25 KB Format: PDF

NRTL Certificate for CNAP® Monitor
Size: 561.55 KB Format: PDF

 

Medical Device Licenses:

Medical Device Licence for Task Force® Monitor
Size: 215.43 KB Format: PDF

Medical Device Licence for Task Force® Monitor Electrodes
Size: 213.02 KB Format: PDF

 

BRAZIL

Certificate of Compliance according to ANVISA

Certificate of Compliance CNAP® Monitor Brazil
Size: 594.26 KB Format: PDF

 


 

 

Patents

CNSystems holds 71 granted and 9 pending patents in 14 different patent families.

View details here.

 

 

 

 

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© CNSystems Medizintechnik GmbH.
  • Innovation
    • CNAP Technology
      • CNAP - Blood Pressure
      • CO - Cardiac Output
      • PPV / SVV - Dynamic Fluid Markers
    • CNAP Finger Sensor
    • ICG Technology
    • Clinical Relevance
      • Blood Pressure Today
      • Early Detection
      • More than just Blood Pressure
      • Goal Directed Therapy
    • Intellectual Property
  • Products
    • Product Portfolio
    • Task Force TOUCH Platform
      • Task Force Touch CARDIO
      • Task Force Monitor Touch
    • CNAP Monitor 500
    • CNAP Partner Solutions
      • Overview
      • CNAP Module
      • Dräger
      • LiDCO
      • BIOPAC
      • NICCI by GETINGE
    • Testimonials
  • Applications
    • Application Range
    • Patient Monitoring
      • Laparoscopic Surgery
      • Orthopedic Surgery
      • Vascular Surgery
      • Cardiology
      • Emergency Care
      • Pediatric Surgery
      • Stroke
      • Anesthesia
      • Fluid Management
      • Cesarian Section
      • COVID-19
    • Research
      • Benefits for Research
      • AcqKnowledge by BIOPAC
      • Psychophysiology
      • Mental Health
      • Sports
      • General Physiology
      • Neurology
    • Diagnosis
      • Syncope Assessment
      • Health Checkup / Prevention
      • VALITUDO - MGM
      • Autonomic Function
      • Pacemaker Optimization
  • News & Events
    • Latest News
    • Upcoming Events
    • Press Releases
    • Publications
  • About Us
    • The CNSystems Group
    • Letter of the CEO
    • Mission & Vision
    • Company History
    • Awards
    • Privacy Protection
    • Imprint
    • COVID-19 Statement
    • Jobs@CNSystems
  • SUPPORT
    • Contact
    • Find Distributor
    • Service Order
    • Product Compliance
    • Literature Service
    • LINKS