Regulatory Compliance

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Quality Management System

CNSystems is certified according to EN ISO 13485, ISO 13485:2016 CMDCAS and PAL/Japan.

EN ISO 13485:2016+AC2016
Size: 235.75 KB Format: PDF

ISO 13485:2016 DQS CMDCAS
Size: 419.36 KB Format: PDF

Japanese PAL Certificate
Size: 349.61 KB Format: PDF

Notified Body

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

mdc medical device certification GmbH

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: 232.61 KB Format: PDF

Declarations of Conformity:

CE Declaration of Conformity for CNAP® Monitor
Size: 697.86 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: 107.22 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.