About Us
Group Information
History (timeline)
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Products
Silicone Medical Product Lines
Silicone Catheters
Surgical Drains & Systems
Enteral Products
Gastrostomy Tubes
Gastrostomy Buttons
NG Tubes
Extension Set
Stoma Measuring Device
Jejunal Tube
Vessel Loops & Clamp Covers
Silicone Tubing
Other Products
Cardiovascular/Vascular Product Lines
Cardiology Devices
Peripheral Devices
Accessories
Medical Devices for Critical Care and Operating Rooms
Centra-Line™
Biovac™
Angio-Line™
Art-Line™
Thorametrix™
Customer Procedure Trays (CPT)
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OEM
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Engineering
Design & Development
Engineers
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Technology
Cardiovascular/Vascular Product Lines
Silicone Medical Product Lines
Medical Devices for Critical Care and Operating Rooms
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Quality
Certifications & Approvals
Quality Assurance & Regulatory Affairs
Complaints Management
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Events
News
Degania Silicone Announces the Acquisition of Controlling Interest in Biometrix
Creating a leading Catheters Specialist & Medical Device Group
Tradeshows
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Contact Us
Corporate HQ, R&D, Silicone Manufacturing
Cardiovascular/Vascular Products, R&D, Manufacturing
Critical Care & Operating Rooms
Marketing, Sales, Warehouse & Distribution
Production Facilities
Home
>>
Quality
>> Certifications & Approvals
Certifications & Approvals
The Degania Medical 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
Download PDF
Biometrix Ltd.
ISO 9001 : 2008
ISO 13485 : 2003
CE: MDD 93/42/EEC
FDA 510(k) US Marketing Clearance
FDA Registration No: 8030115
Down
load PDF
Arthesys SAS
ISO 9001 : 2008
ISO 13485 : 2003
CE : MDD 93/42/EEC
FDA Registration No: 3003646910
Download PDF
Degania Medical Devices Pvt. Ltd.
ISO 9001 : 2008
ISO 13485 : 2003
ISO 14001 : 2004
FDA Registration No: 3005483737
Download PDF
All manufacturing is carried out in accordance with CGMP guidelines.
