BioStream Paclitaxel Eluting PTCA Balloon Catheter
Max. value paid with public resources:
Processing
Data for med. device
Medical device code
07IIIC6221834017
Form date
18/08/2022 13:29
Record date MD
18/08/2022 14:46
Date introduce requestor in the system
10/08/2022 14:04
Identification of the manufacturer
Manufacturer name, long
Biosensors Europe SA
E-mail
j.snoeidecastro@biosensors.com
Identification of the person placing the product on the market
Name of the person placing the product on the market
Marimpex-7 Ltd
Street, number
бул. Цар Борис III N54
Contact person
Adriana Bozhkova
E-mail
office@marimpex7.bg
Identification of the wholesaler
Wholesaler name
Marimpex-7 Ltd
Street, number
бул. Цар Борис III N54
Contact person
Adriana Bozhkova
E-mail
office@marimpex7.bg
Number of authorization/certificate for wholesale trade with medical devices
IV-Р-Т/МИ-186
Date of authorization/certificate for wholesale trade with medical devices
11/12/2007
General medical information about the device
Category of the medical device
07 - Non-active implantable devices
Risk clasification
Class ІІІ
Anatomical group
Cardiovascular system
Generic group
PTCA balloon catheter, drug-eluting
Name
BioStream Paclitaxel Eluting PTCA Balloon Catheter
Description of the medical device
Characteristics
Sterility, Hospital prescription
Drug substance type
Paclitaxel
Intended action by the manufacturer
Purpose
Indicated for patients with discrete lesions of the coronary arteries with a reference vessel diameter of 2.00 mm to 4.00 mm for the purpose of improving the coronary lumen diameter. Indicated for the treatment of coronary in-stent restenosis.
Storage conditions
between 0°C and 25 °
Number in catalog
BSTR-ХХХХ
General trade information
Max. value paid with public resources
Processing
CE certificate number
1434-MDD-036/2020
CE certificate expiration date
27/05/2024
