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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

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

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

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Degania Medical Devices Pvt. Ltd. ISO   9001 : 2008
ISO 13485 : 2003
ISO 14001 : 2004
FDA Registration No: 3005483737

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All manufacturing is carried out in accordance with CGMP guidelines.


 
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