Max. value paid with public resources: Processing

Data for med. device

Medical device code

07IIIC6024596354

Identity type

GTIN

Identity

076401681101XX

Form date

16/09/2021 03:29

Record date MD

16/09/2021 11:03

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

60245

Generic group

Aortic Transcatheter heart valve bio prosthesis,

Name	ACURATE neo2 AORTIC VALVE SYSTEM

Description of the medical device

Number in one package

1

Characteristics

Sterility, Hospital prescription

Material of animal origin type

Porcine pericardial tissue val

Intended action by the manufacturer

Purpose

indicated for relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis who are judged by a Heart Team, including a cardiac surgeon, to be appropriate for the transcatheter heart valve replacement therapy.

Usage

Single use

Number in catalog

SYM-SV2X-004

General trade information

Max. value paid with public resources

Processing

CE certificate number

3812454DE45

CE certificate expiration date

26/05/2024