Max. value paid with public resources: Processing

Data for med. device

Medical device code

07IIIC6230119647

Identity type

GTIN

Identity

088888930XXXXX

Form date

17/08/2022 01:04

Record date MD

26/06/2024 17:25

Date introduce requestor in the system

10/08/2022 14:04

Identification of the manufacturer

Manufacturer name, long

Biosensors Europe SA

Code type

Other

Document type

VAT number

Code	CHE-112.284.230

Country code

CH

City

M

Postal code

1110

Contact person

J

Phone

+412 21 804 80 00

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

Code type

EIK

Code

130489377

Country code

BG

Region code

SOF

City

Sofia

Postal code

1612

Street, number

бул. Цар Борис III N54

Contact person

Adriana Bozhkova

Phone

02 953 25 61

Fax	02 952 58 21

E-mail

office@marimpex7.bg

Identification of the wholesaler

Wholesaler name

Marimpex-7 Ltd

Code type

EIK

Code

130489377

Country code

BG

Region code

SOF

City

Sofia

Postal code

1612

Street, number

бул. Цар Борис III N54

Contact person

Adriana Bozhkova

Phone

02 953 25 61

Fax	02 952 58 21

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

Code type

GMDN

Code value

62301

Generic group

Drug-coated-metal coronary artery stent

Name	BioFreedom Drug Coated Coronary Stent System

Description of the medical device

Ingredient

Stent and the delivery system

Number in one package

1

Characteristics

Sterility, Hospital prescription

Drug substance type

Biolimus A9),

Intended action by the manufacturer

Purpose

The BioFreedom DCS is indicated for improving coronary luminal diameter for the treatment of de-novo lesions in native coronary arteries with a reference diameter ranging from 2.25 mm to 4.0 mm. Stents with length of 33mm and 36mm are only available for artery diameters ranging from 2.5mm to 3.5mm.

Storage conditions

Not store above 25°C

Usage

Single use

Number in catalog

BFR1-ХХХХ

General trade information

Max. value paid with public resources

Processing

CE certificate number

2116857DE04

CE certificate expiration date

31/12/2027