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- Certificate of registration NF EN ISO 13485 : 2016 N°8447 rev.18
Certificate of registration NF EN ISO 13485 : 2016 N°8447 rev.18
Certificate of registration NF EN ISO 13485 : 2016 N°8447 rev.18
This document is a Certificate of Registration issued by GMED, certifying that the quality management system of DISTRICLASS MEDICAL SA and COFRAMED complies with the international standard NF EN ISO 13485:2016. The certificate number is 8447 rev.18, and it is valid from January 13th, 2023, to January 18th, 2026.
- Design, manufacturing, and sales of implantable catheter ports and associated accessories.
- Design, manufacturing, and sales of multiperforated catheters for diffusion and pain management.
- Distribution of medical devices used in cardiology and infusion.
- DISTRICLASS MEDICAL SA, 16 rue Paul Bert, 42000 Saint Etienne, France: Head office.
- DISTRICLASS MEDICAL SA, 110 Allée Louis Lépine, Parc d'Affaires de la Vallée de l'Ozon, 69970 ChaponNay, France: Design, purchases, secondary packaging, and sales.
- COFRAMED, 110 Allée Louis Lépine, Parc d'Affaires de la Vallée de l'Ozon, 69970 ChaponNay, France: Production site.
The certificate was issued by Marjorie Perrimon, Certification Director, on behalf of the President. It renews the previous certificate 8447-17 and is issued according to GMED certification rules. The accreditation number is 4-0608, and further details on accredited sites and scope are available on www.cofrac.fr.
Catalog excerpts
CERTIFICAT CERTIFICATE OF REGISTRATION N° 8447 rev.18 GMED certifie que le systeme de management de la qualite developpe par GMED certifies that the quality management system developed by DISTRICLASS MEDICAL SA 16 rue Paul Bert 42000 ST ETIENNE FRANCE pour les activites for the activities Conception, fabrication et commercialisation de : - Chambres a catheter implantables et accessoires associes, - Catheters multiperfores diffusion - douleur. Distribution de dispositifs medicaux utilises en cardiologie et perfusion. Design, manufacturing and sales of: - Implantable catheter ports and associated accessories, - Multiperforated catheters for diffusion - pain. Distribution of medical devices used in cardiology and infusion. realisees sur le(s) site(s) de performed on the location(s) of DISTRICLASS MEDICAL SA, 110 Allee Louis Lepine - Parc d'Affaires de la Vallee de l'Ozon, 69970 CHAPONNAY, FRA COFRAMED, 110 Allee Louis Lepine - Parc d'Affaires de la Vallee de l'Ozon, 69970 CHAPONNAY, FRA est conforme aux exigences des normes internationales complies with the requirements of the international standards Debut de validite /Effective date : January 13th, 2023 (included) Valable jusqu'au /Expiry date : January 18th, 2026 (included) Etabli le /Issued on : January 13th, 2023 <ofra< -DocuSigned by: sident IMON — 761B7BDEC7B144D.. GMED N° 8447-18 Ce certificat est delivre selon les regies de certification GMED / This certificate is issued according to the rules of GMED certification Accreditation n°4-0608 Liste des sites accredites et portee ^pomb^ sur Renouvelle le certificat 8447-17 GMED • Societe par Actions Simplifiee au capital de 300 000 € • Organisme Notifie/Notified Body n° 0459 Siege social: 1, rue Gaston Boissier - 75015 Paris • Tel. : 01 40 43 37 00 • gmed.fr
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Addendum au certificat N° 8447 rev.18 page 1/1 Addendum of the certificate N° 8447 rev. 18 Dossier / File N° P603735 Ce certificat couvre les activites et les sites suivants : This certificate covers the following activities and sites : ****************************************** DISTRICLASS MEDICAL SA 16 rue Paul Bert 42000 SAINT ETIENNE FRANCE French version : • Siege social. English version : • Head office DISTRICLASS MEDICAL SA 110 Allee Louis Lepine Parc d'Affaires de la vallee de I'Ozon 69970 CHAPONNAY FRANCE French version : • Conception, achats, conditionnement secondaire, commercialisation....
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