successful annual validation for Manufacturer CDM Center of Excellence Ltd. as well as basic and extended manufacturing range of products by Tuev Rheinland in November 2009.
MDD Certificate: Manufacture of disposable infusion sets, disposable syringe sets,dental needles for single use, root canal instruments, sterile absorbent paper points,sterile gutta percha points and sterile latex surgical gloves.
For the following medical devices the scope covers the aspect of manufacture concerned with securing and maintaining sterile conditions: ~ sterile non woven surgical gowns ~ sterile non woven swab ~ sterile absorbent cotton rolls ~sterile dental instrument kits ~ sterile PVC examination gloves ~ sterile nitrile examination gloves.
SX Certificate (EN ISO 13485:2003 + AC: 2007)
Manufacture and Distribution of non woven products: isolation gowns, coveralls,face masks,caps,shoe covers, PE cap, PE apron; gauze swabs, cottonfield sponges,absorbent cotton products; disposable infusion sets,diposable syringe sets;dental bibs,dental needle for single use, root canal instruments,sterile dental instrument kits,sterile absorbent paper points,sterile gutta percha points;PVC examination gloves; Latex examination gloves,nitrile examination gloves, sterile latex surgical gloves.