Max. value paid with public resources: Processing

Data for med. device

Medical device code

06B9B1648858725

Form date

14/01/2019 15:30

Record date MD

14/01/2019 15:49

Date introduce requestor in the system

10/01/2019 11:03

Identification of the manufacturer

Manufacturer name, long

DIAGNOSIS S.A.

Name of the manufacturer, short

DIAGNOSIS

Code type

Other

Document type

VAT

Code	PL5422755590

Country code

PL

City

Białystok

Postal code

15-113

Street, number

ul. Gen. W. Andersa 38 A

Contact person

Marina Bućko

Phone

+48 607 151 936

E-mail

mbucko@diagnosis.pl

Identification of the person placing the product on the market

Name of the person placing the product on the market

DITOMED LTD

Code type

EIK

Code

200048189

Country code

BG

Region code

SOF

City

Sofia

Postal code

1303

Street, number

Ovche pole 122

Contact person

Martin Diankov

Phone

0885079544

E-mail

office@ditomed.bg

Identification of the wholesaler

Wholesaler name

DITOMED LTD

Code type

EIK

Code

200048189

Country code

BG

Region code

SOF

City

Sofia

Postal code

1303

Street, number

Ovche pole 122

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

06 - In vitro diagnostic devices

Risk clasification

The following device for self-diagnosis, including its related calibrators and control materials: device for the measurement of blood sugar

Anatomical group

Blood and blood forming organs

Code type

UMDNS

Code value

16488

Name	ABRA glukometer

Alternative name

glukometer

Model

REF. 0468

Description of the medical device

Number in one package

1

Size	92x58x19 mm

Weight

60 gr

Characteristics

Measuring, Domestic prescription, Hospital prescription

Intended action by the manufacturer

Usage

Reusable

Number in catalog

REF. 0468

Accessories, consumables

Name Model Reference/catalog number Description ABRA test strips REF. 0470 REF. 0470 test strips ABRA control solution REF. 0471 REF. 0471 control solution ABRA control solution REF. 0472 REF. 0472 control solution ABRA control solution REF. 0473 REF. 0473 control solution

General trade information

Max. value paid with public resources

Processing

BDA registration number

IV-Р-Т/МИ 579

BDA registration date

01/07/2010

CE certificate number

HL 60118565 0001

CE certificate expiration date

11/03/2022