關於合世

 FDA 510(K) Certificate

 

 

>510(K) 168 Series
>510(K) 200 Series
>510(K) 888 Series
>510(K) HL188, HL189

 

 國際認證

 

 

1.Certificate for EN ISO 13485 (MD) (2013.08.08)

2.Certificate for EN ISO 9001 (MD) (2013.08.08)

3.Certificate for ISO 13485 (IVD) (2013.09.06)

4.Certificate for CMDCAS ISO 13485 (MD) (2015.07.08)

5.Certificate for CMDCAS ISO 13485 (IVD) (2014.08.29)

6.CMDCAS Certificate for BPM (Wrist Type & Arm Type) (License Number 63811) (2013.08.12)

7.CMDCAS Certificate for Vib-Mesh Nebulizer (License Number 85648) (2011.11.17)

8.CMDCAS Certificate for Infrared Thermometers (License Number 88103) (2012.01.18)

9.Certificate for Directive 93/42/EEC (2014.02.19)

10.Certificate for Directive 98/79/EC   (2014.09.29)

11.TFDA Medical Device License _ Taiwan

12.JPAL _ Japan