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The Degania MedicalTM companies have the following certification:
 
Degania Silicone Ltd. ISO   9001 : 2008
ISO 13485 : 2003
ISO 14001 : 2004
CE : MDD 93/42/EEC
FDA 510(k) US Marketing Clearance
FDA Registration No: 8030107
CMDCAS



 
Biometrix Ltd. ISO   9001 : 2008
ISO 13485 : 2003
CE:  MDD 93/42/EEC
FDA 510(k) US Marketing Clearance
FDA Registration No: 8030115
 

Biometrix Slovakia. Annual report 2016 on the functionality of an individual handling system - wastes from packaging
 

Arthesys SAS. ISO   9001 : 2008
ISO 13485 : 2003
CE : MDD 93/42/EEC
FDA Registration No: 3003646910

Degania Medical Devices Pvt. Ltd. ISO 13485:2012
ISO 13485 : 2003
ISO 14001 : 2004
FDA Registration No: 3005483737
OHSAS 18001:2007


All manufacturing is carried out in accordance with CGMP guidelines.


 
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