Max. value paid with public resources: Processing

Data for med. device

Medical device code

11IIaV3467143821

Form date

28/02/2022 09:07

Record date MD

28/02/2022 14:09

Date introduce requestor in the system

15/12/2021 16:15

Identification of the manufacturer

Manufacturer name, long

Ear Teknik Isitme ve Odiometri Cihazlari San.veTic

Name of the manufacturer, short

Ear Teknik Isitme ve Odiometri

Code type

Other

Document type

Letter of Authorization

Code	12.02.2021

Country code

TR

City

Tekirdağ

Postal code

59930

Street, number

Avrupa Serbest Bölgesi Adnan Arısoy Blv. No:13/305

PO box

1

Contact person

IZZET ALAGOZ

Phone

00902125579168

Fax	00902125579168

E-mail

izzet@eartechnic.com

Identification of the person placing the product on the market

Name of the person placing the product on the market

SANITAS MEDICAL EOOD

Code type

EIK

Code

205445807

Country code

BG

Region code

SOF

City

Sofia

Postal code

1504

Street, number

TZAR OSVOBODITEL 25

PO box

1

Contact person

EMIL KYUCHUKOV

Phone

0888880593

Fax

029433838

E-mail

dr.kyuchukov@gmail.com

Identification of the wholesaler

Wholesaler name

SANITAS MEDICAL EOOD

Code type

EIK

Code

205445807

Country code

BG

Region code

SOF

City

Sofia

Postal code

1504

Street, number

TZAR OSVOBODITEL 25

PO box

1

Contact person

EMIL KYUCHUKOV

Phone

0888880593

Fax

029433838

E-mail

dr.kyuchukov@gmail.com

Number of authorization/certificate for wholesale trade with medical devices

BG/WDA/MD-0447

Date of authorization/certificate for wholesale trade with medical devices

12/08/2021

General medical information about the device

Category of the medical device

11 - Assistive products for persons with disability

Risk clasification

Class ІІ a

Anatomical group

Various

Code type

GMDN

Code value

34671

Generic group

HEARING AIDS

Name	PROGRAMMABLE HEARING AIDS

Alternative name

PROGRAMMABLE HEARING AIDS

Model

FORCE 300

Intended action by the manufacturer

Purpose

HEARING AID

Usage

Reusable

Number in catalog

FORCE 300

General trade information

Max. value paid with public resources

Processing

BDA registration number

IAL 1523

BDA registration date

14/01/2014

Release date for the market in Republic Bulgaria

20/01/2014

CE certificate number

1984-MDD-20-685

CE certificate expiration date

27/05/2024