Max. value paid with public resources: Processing

Data for med. device

Medical device code

10IIIC6255162390

Form date

14/09/2023 10:10

Record date MD

14/09/2023 11:36

Date introduce requestor in the system

11/09/2023 16:09

Identification of the manufacturer

Manufacturer name, long

Concept Medical B.V.

Code type

Other

Document type

N/A

Code

N/A

Country code

NL

City	Hoevalaken

Postal code

3871

Street, number

Hogebrinkerweg 33

Contact person

Jos De Korte

Phone

+31 (0)651 668 923

E-mail

gm@conceptmedicals.eu

Identification of the person placing the product on the market

Name of the person placing the product on the market

Cardio Medical Ltd

Code type

EIK

Code

201980901

Country code

BG

Region code

SOF

City

Sofia

Contact person

Aleksandar Madzharov

Phone

+35929533616

E-mail

cardiomedical@abv.bg

Identification of the wholesaler

Wholesaler name

Cardio Medical Ltd

Code type

EIK

Code

201980901

Country code

BG

Region code

SOF

City

Sofia

Contact person

Aleksandar Madzharov

Phone

+35929533616

E-mail

cardiomedical@abv.bg

Number of authorization/certificate for wholesale trade with medical devices

IV-Р-Т/МИ 827

Date of authorization/certificate for wholesale trade with medical devices

08/05/2012

General medical information about the device

Category of the medical device

10 - Single-use devices

Risk clasification

Class ІІІ

Anatomical group

Cardiovascular system

Code type

GMDN

Code value

62551

Name	Magic Touch AVF-Sirolimus Coated PTA Balloon

Alternative name

Catheter (0.035" OTW)

Description of the medical device

Characteristics

Sterility, Hospital prescription

Intended action by the manufacturer

Purpose

Sirolimus Drug-Coated Balloon - Indicated for the treatment of stenotic lesions of dysfunctional arteriovenous fistula and graft.

Usage

Single use

General trade information

Max. value paid with public resources

Processing

CE certificate number

1434-MDD-499/2019

CE certificate expiration date

27/05/2024