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Качество

ELLA-CS, s.r.o. possesses the following certificates concerning QMS and medical devices:

Quality Management System
QMS Certificate No: 8070001

Issued by: The Electotechnical Testing Institute, Prague, Czech Republic
Scope of Certificate: Design and Development, Production, Sale and Distribution of Medical Devices in these categories: Stents Systems for gastrointestinal tract, Endovascular Stents Systems, Impantable Ports, Vena Cava Filters, Stents Extractors, Opthalimic Implants, Angioplasty catheters, Special Injections Needles for Ports, Prostatic Stents
Validity period: 2009 - December 31

Applied Standard(s): EN ISO 13485: 2003, Quality Systems - Medical Devices - Quality Management Systems - includements for regulatory purposes

Medical Device
EC - Certificate No. MED 070001
Issued by: The Electrotechnical Testing Institute (EZU), Prague, Czech Republic, Notified Body No. 1014

Products:
SX-ELLA Stent Biliary (model 01 - Nitinella), IIb
SX-ELLA Stent Pyloroduodenal (model 04 - Enterella), IIb
SX-ELLA Stent Colorectal (model 05 - Enterella), IIb
SX-ELLA Esophageal Stent (model 06 - Flexella - PUSH delivery system, model 07 - Flexella - PULL delivery system), IIb
SX-ELLA Esophageal HV (model 08 - HV Stent), IIb
SX-ELLA Stent Danis (Danis Stent), IIb
FerX-ELLA Esophageal Stent (types: Classic, Boubella, Boubella E), IIb
SX-ELLA Stent TIPS (model 02), IIb
SX-ELLA Stent Endovascular (model 03), IIb
ELLA Port Set (ELLA Port), III
ELLA Filter Set (ELLA Filter), III
Extractor of SX-ELLA Stent Danis (Pexella), IIa
Extractor of SX-ELLA Stents Esophageal (ELLA Extractor), IIa
Silicone Tubes for Nasolacrimal Pathways, IIb
Glaucoma Filtration Implants, IIb
Implants Designed for Treatment of Retinal Detachment, IIb
Orbital Implants, IIb
ELLA PTA Balloon Catheter (ELLA PTA Catether), IIa
Special Injection Needle for Ports, IIa
Special Injection Needle (MANTELLA), IIa
Prostatic ELLA Spiral - PES, IIb
Validity period: 2011 - December 31

The company ELLA-CS, s.r.o. is subjected to regular annual audits performed by notified bodies that check QMS and manufacture of medical devices. The last audits were performed in December 2006 (Electrotechnical Testing Institute, Prague, Czech Republic).