System Certificates:

  ISO 9001:2008 in 2012 by BSI
  ISO 13485 : 2003 in 2012 by BSI

Product License:

● FDA 510(K)
  K014002
  K021142
  K021193
  K022112
  K980917
  K980919
  Listing for Class I products.
     
● CE MARK 
  MDD 93/42/EEC Annex Ⅱ 3.2 by BSI
  MDD 93/42/EEC Annex V by BSI
     
● Taiwanese Medical Device Registered
  All products range.
     
Migration of CE certificates
BSI Netherlands would like to confirm the successful reassignment of your certificate(s) from BSI Notified Body 0086 UK to the NL Notified Body 2797. 

Change Notification for the Notified Body number_ Fortune medical

Certificate Migration Letter issued by the notified body

New CE certificates (CE 588902)_ Fortune Medical

New CE certificates (CE 589950)_ Fortune Medical

 

 

 

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