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TenaTac® is manufactured by CuraMedical B.V. in Assendelft, The Netherlands.

CuraMedical relies on a substantial record of sales without reportable complaints or adverse incidents. The quality manual of CuraMedical B.V. and further required documented procedures have been reviewed by Notified Body MDC (CE 0483) with respect to the requirements of the Medical Device Directive 93/42/EEC, Annex II, and EN ISO 13485:2016.

CuraMedical's ISO 13485:2016 Quality Management System Certificate

The design dossiers and technical files for TenaTac have been successfully examined and awarded CE certification by Notified Body MDC, Stuttgart, Germany (CE0483).

For the full scope of Sterile absorbable and non-absorbable haemostats:

CuraMedical EC Quality System CertificateCuraMedical EC Design Examination Certificate
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