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| QUALITY ASSURANCE | ||||
| The
company LIFE LINE plus s.r.o. is a manufacturer of
oxidised-cellulose based medical devices destined to stop bleeding, sold
and distributed under the brand name BLOODCARE. These professional
haemostatic agents are produced under the certified Quality Management
System in compliance with standards EN ISO 9001:2008 and EN ISO
13485:2003.
Due to the fact that they all belong to II to III classification groups according to DIR 93/42 EEC and Government Direction No. 336/2004 Sb., all of them have been approved and certified by a reputable Notified Body No. 1023 and consequently have been provided with the CE mark. Further more, Declaration of Conformity has been issued for all the BLOODCARE medical devices. |
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| With the above mentioned facts, you have the full guarantee that the our high-class haemostatic agents sold and distributed under the brand name BLOODCARE meet all the EC requirements on quality of our medical devices. | ||||
| We
would be really pleased if our haemostats BLOODCARE fully corresponded
with your ideas and if the quality was to your full satisfaction.
However, should there be any proposals of how the quality, the end-user
comfort and efficiency could be improved, and you as professional
end-users have ideas and/or suggestions on it, we will really appreciate
if we can share them with you.
With this regard, please feel free to contact us on e-mail: info@lifeline.cz |
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| CSN EN ISO 9001:2009 | EN ISO 13485:2003 | EC PRODUCT CERTIFICATE | EC Design Examination (BLOODCARE powder) | EC Design Examination (BLOODCARE matrix) |