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 2021.08.29
Valid until 2024.08.28
> Download - MDSAP ISO 13485 : 2016
Valid from 2021.08.06
Valid until 2024.08.05
CE:0483mediCAD® 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)
UK MHRA CertificateCertified by Medicines & Healthcare Products Regulatory Agency
Confirmed: 17 January, 2022
Account No: 0000021281
> Download - UK MHRA Certificate
FDA 510(k): K170702 (USA) / K183412 (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 mediCAD®
> Download - Certificate mediCAD® Web
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
P3H 2017/6580 (Russia)Registration certificate for medical device No. P3H 2017/6580
First Issue Date: December 15th, 2017
> Download Certificate
Authorised Representative License (Kingdom of Saudi Arabia)License Number: ARL-2021-MD-0146
Issuing date / Expiry date: 2021.01.13 - 2026.01.26
> Download AR License
DEKRA Certification Japan K.K. (Japan)Registration certificate for medical device No. 30IAOBZXO0004000
First Issue Date: September 12th, 2019
> Download Certificate
DV-2017-MC-06752-1 (AUS)Australian Register of Therapeutic Goods Certificate / ARTG Identifier 291391
ARTG Start Date: 12/07/2017
> Download Certificate
DEU 6302169 / AP-2697-22-D3816-D773/2020Thailand Certificate
> Download Certificate
Registro ANVISA nº 80002050001 (BRA)for mediCAD® Classic, mediCAD® Hip 3D, mediCAD® Knee 3D, mediCAD® Spine 3D
Decision date: February 20, 2018
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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)
