Max. value paid with public resources: Processing

Data for med. device

Medical device code

09IIbV4461168108

Form date

19/07/2021 10:29

Record date MD

19/07/2021 11:11

Date introduce requestor in the system

17/03/2021 15:00

Identification of the manufacturer

Manufacturer name, long

Dexcom Inc.

Code type

Other

Document type

N/A

Code

999999

Country code

US

City

San Diego

Postal code

6340

Contact person

Minako Shimomura

Phone

1-888-738-3646

E-mail

EMEARegulatory@dexcom.com

Identification of the person placing the product on the market

Name of the person placing the product on the market

Sopharma Trading JSC

Code type

EIK

Code

103267194

Country code

BG

Region code

SOF

City

Sofia

Postal code

1756

Street, number

Luchezar Stanchev 5

Contact person

Stefka Hradlichkova

Phone

+359 2 81 33 666

E-mail

RP@sopharmatrading.bg

Identification of the wholesaler

Wholesaler name

Sopharma Trading JSC

Code type

EIK

Code

103267194

Country code

BG

Region code

SOF

City

Sofia

Postal code

1756

Street, number

Luchezar Stanchev 5

Contact person

Stefka Hradlichkova

Phone

+359 2 81 33 666

E-mail

RP@sopharmatrading.bg

Number of authorization/certificate for wholesale trade with medical devices

IV-P-T/МИ-259

Date of authorization/certificate for wholesale trade with medical devices

09/01/2008

General medical information about the device

Category of the medical device

09 - Reusable devices

Risk clasification

Class b

Anatomical group

Various

Code type

GMDN

Code value

44611

Name	Dexcom ONE Continuous Glucose Monitoring System

Model

Dexcom ONE Transmitter

Description of the medical device

Characteristics

Measuring, Domestic prescription

Intended action by the manufacturer

Usage

Reusable

General trade information

Max. value paid with public resources

Processing

CE certificate number

CE 591560

CE certificate expiration date

26/05/2024