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Quality Certificate

ISO 9001:2000 and ISO 13485:2003
The quality system of Royal Fornia Medical Equipment Co., Ltd. has been certified by CMD according to the standard of ISO 9001:2000 under certificate number 04707Q10080RIM and the standard of ISO 13485 under certificate number 04707Q10000086.

   

                                                         

ISO13485 
TüV Product Service GmbH has certified the quality system of Royal Fornia Medical Equipment Co., Ltd. according to the standard of ISO 13485:2003 under certificate number Q1N 06 09 54466 004

                                                                       

CE for disposable infusion pump
The Disposable Infusion Pump is CE certified by TüV Product Service GmbH according to Annex II section 3 of the Directive 93/42/EEC. The EC-certificate number G1 05 01 54466 003

                    

CE for disposable Central Venous Catheter
The Disposable Infusion Pump is CE certified by TüV Product Service GmbH according to Annex II section 4 of the Directive 93/42/EEC. The EC-certificate number G7 07 08 54466 005

  

TÜV Product Service GmbH is Notified Body according to Council Directive 93/42/EEC concerning medical devices with identification number 0123

 

      

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