Regulatory compliance / Registration certificates

flagge EU EN ISO 13485:2016 (MDSAP Audit Model Edition 2)
The Quality Management System of company mediCAD Hectec GmbH is certified according to EN ISO 13485.
Certified by mdc medical device certification GmbH
> Download - Certificate EN ISO 13485
Valid from 2018.08.29
Valid until 2021.08.28
> Download - MDSAP Audit Model Edition 2
Valid from 2018.07.30
Valid until 2021.07.29

flagge EU CE:0483
mediCAD® complies with the basic requirements of the Council Directive 93/42/EEC as provided by the Quality System and is approved as a Class 1 medical product in accordance with this directive.
Certified by mdc medical device certification GmbH
> Download - EC Certificate mediCAD
> Download - Certyficat WE (PL)

flagge US FDA 510(k): K170702 (USA)
510(k) clearance for mediCAD® has been granted by the FDA.
Decision date: July 9th, 2018
Decision: Substantially Equivalent (SESE)
> read more
> Download - Certificate

flagge CAN MDL 95559 (CANADA)
Completion of the 2015-2016 NEW Medical Device Licence Process
First Issue Date: August 11th, 2015
> Download - 512917 MDSAP16
> Download - MDL 95559 Certificate

flagge RU P3H 2017/6580 (Russia)
Registration certificate for medical device No. P3H 2017/6580
First Issue Date: December 15th, 2017
> Download Certificate

DEKRA Certification Japan K.K. (Japan)
Registration certificate for medical device No. 30IAOBZXO0004000
First Issue Date: September 12th, 2019
> Download Certificate

flagge AUS DV-2017-MC-06752-1 (AUS)
Australian Register of Therapeutic Goods Certificate / ARTG Identifier 291391
ARTG Start Date: 12/07/2017
> Download Certificate

flagge Thailand DEU 6302169 / AP-2697-22-D3816-D773/2020
Thailand Certificate
> Download Certificate

flagge BRA Registro ANVISA nº 80002050001 (BRA)
for mediCAD® Classic, mediCAD® Hip 3D, mediCAD® Knee 3D, mediCAD® Spine 3D
Decision date: February 20, 2018
> read more

flagge COLUM Resolution No. 2017045685 (Republica de Columbia)
Decreto Regulamentario 4725 de 2005, ley 1437 de 2011 y ley 962 de 2005
> Download Resolution (Decision date: October 27, 2017)
> The registration of the mediCAD® Brand (Resolución No. 12123, April 2, 2018)
> Trademark certificate (Resolución No. 22439, April 2, 2018)