Max. value paid with public resources: Processing

Data for med. device

Medical device code

13IIaR1287301431

Form date

12/11/2019 12:04

Record date MD

13/11/2019 10:01

Date introduce requestor in the system

12/11/2019 09:22

Identification of the manufacturer

Manufacturer name, long

SHENYANG AERTI TECH CO., LTD

Name of the manufacturer, short

AERTI

Code type

Other

Document type

НЯМА КОД

Code

xxxxxxxxx

Country code

CN

City	Shenyang City

Postal code

110141

Street, number

No. 30 Huahai Road

Contact person

Ms. Ada Qi

Phone

+86-24-25335433

Fax	+86-24-25335411

E-mail

ada@airtech-med.com

Identification of the person placing the product on the market

Name of the person placing the product on the market

ДИТОМЕД ЕООД

Code type

EIK

Code

200048189

Country code

BG

Region code

SOF

City

Sofia

Postal code

1303

Contact person

Martin Diankov

Phone

0885079544

E-mail

office@ditomed.bg

Identification of the wholesaler

Wholesaler name

ДИТОМЕД ЕООД

Code type

EIK

Code

200048189

Country code

BG

Region code

SOF

City

Sofia

Postal code

1303

Contact person

Martin Diankov

Phone

0885079544

E-mail

office@ditomed.bg

Number of authorization/certificate for wholesale trade with medical devices

IV-Р-Т/МИ 579

Date of authorization/certificate for wholesale trade with medical devices

01/07/2010

General medical information about the device

Category of the medical device

13 - Complementary therapy devices

Risk clasification

Class ІІ a

Anatomical group

Respiratory system

Code type

UMDNS

Code value

12873

Name	AR Oxygen Concentrator-AR-5

Alternative name

AR Oxygen Concentrator-AR-5

Description of the medical device

Characteristics

Domestic prescription, Hospital prescription

Intended action by the manufacturer

Purpose

An oxygen concentrator is a device that concentrates the oxygen from a gas supply (typically ambient air) by selectively removing nitrogen to supply an oxygen-enriched product gas stream.

Usage

Reusable

Number in catalog

AR-5

General trade information

Max. value paid with public resources

Processing

BDA registration number

IV-Р-Т/МИ 579

BDA registration date

01/07/2010

Release date for the market in Republic Bulgaria

12/11/2019

CE certificate number

DD 60100205 0001

CE certificate expiration date

08/04/2020