ISO 9001 N° QUAL/2000/14985
Pour les activités suivantes :
CONCEPTION, FABRICATION ET VENTE DE MODULES DE DESINFECTION DES ENDOSCOPES ET NEGOCE D’ACCESSOIRES.
ISO 13485 N° MED/2000/14986a
Pour les activités suivantes :
CONCEPTION, FABRICATION ET VENTE DE MODULES DE DESINFECTION DES ENDOSCOPES ET NEGOCE D’ACCESSOIRES.
CE Marking
Endoscope disinfection benches are medical devices as defined by Articles L665-3 and R665-1 of the Code de la Santé Publique (French public health law) and are in Class IIa of rule 15. Consequently, since June 14th 1998, they must be CE marked and an approved body must validate this. We chose the CTM-APAVE (CE 0398) for this validation.
Directive 93/42/CEE of June 14th 1993 concerning medical devices
Information: Agence française de sécurité sanitaire des produits de santé, 143-147 Bd Anatole France, 93285 Saint Denis Cedex, France (French healthcare products safety body)
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