Max. value paid with public resources: Processing

Data for med. device

Medical device code

07IIIC4773211709

Identity type

GTIN

Identity

H749 389XXXXXXX

Form date

07/06/2013 23:44

Record date MD

28/11/2022 11:02

Date introduce requestor in the system

19/03/2013 12:07

Identification of the manufacturer

Manufacturer name, long

Boston Scientific Corporation

Name of the manufacturer, short

Boston Scientific

Code type

EIK

Code

802024099

Country code

US

City	Marlborough

Postal code

MA 01752

Contact person

Bodzan, Renata

Phone

0048607410800

E-mail

Renata.Bodzan@bsci.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

bul.Tzar Boris III 54

Contact person

Adriana Bozhkova

Phone

9532561

Fax

9525821

E-mail

marimpex-7@mbox.contact.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

bul.Tzar Boris III 54

Contact person

Adriana Bozhkova

Phone

9532561

Fax

9525821

E-mail

marimpex-7@mbox.contact.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

47732

Generic group

Catheter, Angioplasty, Balloon Dilatation

Name	APEX Monorail and OTW Dilatation Catheters

Alternative name

Balloon APEX MONORAIL; Balloon APEX OTW

Description of the medical device

Material type

OptiLEAP

Characteristics

Sterility, Hospital prescription

Intended action by the manufacturer

Purpose

The Apex OTW and Apex Monorail PTCA Dilation Catheters (balloon models 1.50-5.00 mm) are indicated for the balloon catheter dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.

Usage

Single use

Others

Apex Monorail PTCA Dilatation Catheter - 1,50mm x 8mm through 4mm x 30mm Apex Over-The-Wire PTCA Dilatation Catheter - 1,50mm x 8mm through 4mm x 30mm

Number in catalog

H749 389XXXXXXX

General trade information

Max. value paid with public resources

Processing

CE certificate number

3812454DE17

CE certificate expiration date

26/05/2024