Max. value paid with public resources: Processing

Data for med. device

Medical device code

07IIIC6024576735

Identity type

GTIN

Identity

SYM-SV2X-002XXX

Form date

09/01/2018 04:02

Record date MD

11/01/2018 15:44

Date introduce requestor in the system

05/01/2018 14:57

Identification of the manufacturer

Manufacturer name, long

Symetis SA

Code type

EGN

Code	7210216276

Country code

CH

City

ECUBLENS

Postal code

CH-1024

Street, number

Chemin de Ia Venoge, 11

Contact person

Julie Sanford

Phone

0048224186734

E-mail

Julie.Sanford@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 N 54

Contact person

Adriana Bozhkova

Phone

02 9532561

Fax	02 9595821

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

bul.Tzar Boris III N 54

Contact person

Adriana Bozhkova

Phone

02 9532561

Fax	02 9595821

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

60245

Generic group

Aortic Bioprosthesis

Name	ACURATE neo™ AORTIC BIOPROSTHESIS

Description of the medical device

Number in one package

1

Characteristics

Sterility, Hospital prescription

Intended action by the manufacturer

Purpose

The ACURATE neo™ Aortic Bioprosthesis and its Delivery System are indicated for use in patients 75 years of age and older with severe aortic stenosis. for whom conventional surgical aortic valve replacement is considered high risk for mortality or who are not operable

Usage

Single use

Number in catalog

SYM-SV2X-002

General trade information

Max. value paid with public resources

Processing

CE certificate number

252.922

CE certificate expiration date

25/06/2020