Quality
Quality
CuraMedical can rely on a substantial record of sales without reportable complaints or adverse incidents which has proven our product’s efficacy and performance. The quality manual of CuraMedical B.V. and further required documented procedures have been reviewed by the notified body MDC (CE 0483) with respect of the requirements of the Medical Device Directive 93/42/EEC, Annex II, and EN ISO 13485:2016.
Download our ISO 13485:2016 Quality Management System Certificate
The design dossiers and technical files for the products Curaspon®, Curacel® and Curatamp® have been successfully examined and awarded CE certification by Notified Body MDC, Stuttgart, Germany (CE0483). Our EC certificates and Declarations of Conformity (DOC) can be downloaded below:
- CuraMedical EC Quality System Certificate for the full scope of Sterile absorbable and non-absorbable haemostats
- CuraSpon EC Design Examination Certificate and CuraSpon DOC
- CuraCel Standard EC Design Examination Certificate and CuraCel Standard DOC
- CuraCel High Density EC Design Examination Certificate and CuraCel High Density DOC
- CuraCel Fibrillar EC Design Examination Certificate and CuraCel Fibrillar DOC
- CuraTamp Standard EC Design Examination Certificate and CuraTamp Standard DOC
- CuraWax EC Design Examination Certificate and CuraWax DOC
Instructions for use
Curaspon® CE Certificate
Curacel® Standard Knit CE Certificate
Curacel® High Density CE Certificate
Curacel® Fibrillar CE Certificate
Curatamp® CE Certificate
Qualified Partner
Continuously striving to offer exceptional quality and value, the company uses leading-edge technology to ensure an outstanding and reliable product performance.
