CERTIFICATE OF REGISTRATION This is to certify that
TERRATS MEDICAL S.L. Calle Mogoda 75-99, Barbera del Valles, Barcelona 08210 Spain operates a
Quality Management System which complies with the requirements of
ISO 13485:2003 for the following scope of certification Design, development and manufacture of clinical screws abutments, interfaces and instruments for dental implantology purpose.
Certificate No.: CERT-0075471 File No.: 1639918
Original Certification Date: June 7, 2013 Certification Effective Date: June 6, 2016 Certification Expiry Date: December 31, 2018
Nicole Grantham ________________________________________________________________________________ General Manager SAI Global Certification Services CMDCAS Recognized Registrar
ISO 13485:2003 Registered by: QMI-SAI Canada Limited (SAI Global), 20 Carlson Court, Suite 200, Toronto, Ontario M9W 7K6 Canada. This registration is subject to the SAI Global Terms and Conditions for Certification. While all due care and skill was exercised in carrying out this assessment, SAI Global accepts responsibility only for proven negligence. This certificate remains the property of SAI Global and must be returned to them upon request. To verify that this certificate is current, please refer to the SAI Global On-Line Certification Register: www.qmi-saiglobal.com/qmi_companies/
Santé Health Canada Canada
LN/NH:
Medical Device Licence
Therapeutic Products Directorate Medical Devices Bureau Direction des produits thérapeutiques Bureau des matériels médicaux
94512
Homologation d'un instrument médical * MODIFIÉE *
* AMENDED *
Licence Number:
94512
No d'homologation:
First Issue Date:
2015/01/15
Première date de délivrance:
Amended Date:
2017/06/02
Date de modification:
Device Class/Classe de l'instrument: 3 This Licence is issued in accordance with the Medical Devices Regulations, Section 36, for the following medical device:
La présente homologation est délivrée en vertu de l'article 36 du Règlement sur les instruments médicaux pour l'instrument médical suivant:
Licence Name/Nom de l'homologation: DESS DENTAL SMART SOLUTIONS
Licence Type/Type d'homologation: System / Système
Reason for Amendment/Raison de la modification CHANGE IN MANUFACTURER'S ADDRESS
Manufacturer Name & Address/Nom du fabricant & adresse TERRATS MEDICAL S.L. CALLE MOGODA 75-99 BARBERA DE VALLES BARCELONA SPAIN 08210
Kimby Barton, Interim Director, Medical Devices Bureau/Directrice intérimaire, Bureau des matériels médicaux _________________________________________________________
Application Number: Numéro de la demande:
269150
Manufacturer ID: Identificateur du fabricant:
138618