Max. value paid with public resources: Processing

Data for med. device

Medical device code

06А2V4044323848

Identity type

GTIN

Identity

40443

Form date

07/09/2021 10:11

Record date MD

07/09/2021 12:13

Date introduce requestor in the system

03/05/2018 16:44

Identification of the manufacturer

Manufacturer name, long

Artron Laboratories Inc.

Name of the manufacturer, short

Artron Laboratories Inc.

Code type

Other

Document type

ISO 13845

Code

745005053

Country code

CA

City	Burnaby, BC

Street, number

3938 North Fraser Way

Contact person

Sunny Miao

Phone

+1(604)415-9757 EXT:116

Fax	+1(604)415-9795

E-mail

sunnym@artronbio.com

Identification of the person placing the product on the market

Name of the person placing the product on the market

Dans Pharma Ltd.

Code type

EIK

Code

130868975

Country code

BG

Region code

SOF

City

Sofia

Postal code

1202

Street, number

str.Industrialna 11

Contact person

Damyana Marinova

Phone

02/9367079

Fax	02/9367792

E-mail

sales2@danspharma.com

Identification of the wholesaler

Wholesaler name

Dans Pharma Ltd.

Code type

EIK

Code

130868975

Country code

BG

Region code

SOF

City

Sofia

Postal code

1202

Street, number

str.Industrialna 11

Contact person

Damyana Marinova

Phone

02/9367079

Fax	02/9367792

E-mail

sales2@danspharma.com

Number of authorization/certificate for wholesale trade with medical devices

IV-P-T/МИ-764

Date of authorization/certificate for wholesale trade with medical devices

23/11/2011

General medical information about the device

Category of the medical device

06 - In vitro diagnostic devices

Risk clasification

Reagents and reagent products, including related calibrators and control materials, for the detection, confirmation and quantification in human specimens of markers of HIV infection (HIV 1 and 2), HTL

Anatomical group

Various

Code type

GMDN

Code value

40443

Name	Hepatitis B Virus Surface Antigen (HBsAg) Strip

Intended action by the manufacturer

Usage

Single use

Number in catalog

A02-01-213

General trade information

Max. value paid with public resources

Processing

CE certificate number

2018-IVD/DE-005

CE certificate expiration date

25/08/2023