Identification of the person placing the product on the market
GENESIS HEALTH Ltd.
EIK
205259756
BG
PDV
Plovdiv
Lidia Panova
+359886806046
info@genesishealth.bg
Identification of the wholesaler
GENESIS HEALTH Ltd.
EIK
205259756
BG
PDV
Plovdiv
Lidia Panova
+359886806046
info@genesishealth.bg
БГ/WDA/MD-0105
28/01/2019
General medical information about the device
07 - Non-active implantable devices
Class ІІІ
Cardiovascular system
GMDN
44307
TEMREN Atherectomy System
Description of the medical device
Sterility, Hospital prescription
Intended action by the manufacturer
The TEMREN Atherectomy System is used to open occlusions and stenosis that occur in acute, subacute and chronic periods, especially in arterial peripheral occlusions. The TEMREN Atherectomy System offers a powerful, effective and safe solution, even for challenging stenosis. TEMREN Atherectomy System, with its diamond tip structure, effectively cleans including extremely hard stenosis without damaging the vessel. TEMREN Atherectomy System is offered to the market in 5F, 6F and 7F diameter, 90 and 135 cm length variants. 0.014" ' 0.018" guide wire is compatible. !t is designed to be used in the treatment of arterial peripheral occlusions, in the treatment of acut6, subacute and chronic occlusions and stenosis
