Max. value paid with public resources: Processing

Data for med. device

Medical device code

07IIIC6024552492

Identity type

GTIN

Identity

426050866XXXX

Form date

15/09/2021 16:56

Record date MD

05/08/2022 11:05

Date introduce requestor in the system

03/09/2021 10:03

Identification of the manufacturer

Manufacturer name, long

NVT GmbH

Code type

EGN

Code	5709216778

Country code

DE

City

Hechingen

Postal code

72379

Street, number

Lotzenäcker 17

Contact person

Holger Sigg

Phone

+49 (0) 7471-98979-0

Fax	+49 (0) 7471-98979-222

E-mail

regulatory@nvt-med.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 Transcatheter heart valve

Name	ALLEGRA Transcatheter Aortic Valve Imp-ion System

Description of the medical device

Number in one package

1

Characteristics

Sterility, Hospital prescription

Material of animal origin type

bovine pericardium

Intended action by the manufacturer

Purpose

The ALLEGRA Transcatheter Aortic Valve Implantation System TF is indicated for the treatment of severe calcified aortic valve stenosis in high risk patients with elevated surgical risk or in patients with a symptomatic degeneration of an aortic valve bioprosthesis.

Usage

Single use

Number in catalog

THV-AO00XXG1RE

General trade information

Max. value paid with public resources

Processing

CE certificate number

51380-61-A0

CE certificate expiration date

28/07/2027