Max. value paid with public resources: Processing

Data for med. device

Medical device code

13IIbV1164127775

Form date

13/01/2014 13:37

Record date MD

13/01/2014 13:51

Date introduce requestor in the system

12/06/2013 14:38

Identification of the manufacturer

Manufacturer name, long

UNIPHARM AD

Name of the manufacturer, short

UNIPHARM AD

Code type

EIK

Code

831537465

Country code

BG

Region code

SOF

City

Sofia

Postal code

1797

Street, number

Traiko Stanoev 3

Contact person

Rositsa Balkandzhyiska

Phone

02/970 03 41

Fax	02/971 20 86

E-mail

rosi@unipharm.bg

Identification of the person placing the product on the market

Name of the person placing the product on the market

UNIPHARM AD

Code type

EIK

Code

831537465

Country code

BG

Region code

SOF

City

Sofia

Postal code

1797

Street, number

Traiko Stanoev 3

Contact person

Rositsa Balkandzhyiska

Phone

02/970 03 41

Fax	02/971 20 86

E-mail

rosi@unipharm.bg

General medical information about the device

Category of the medical device

13 - Complementary therapy devices

Risk clasification

Class b

Anatomical group

Various

Code type

UMDNS

Code value

11641

Generic group

Concentrate for haemodialysis

Name	Acid bicarbonate concentrate CHD- A44.10

Description of the medical device

Ingredient

Na+, K+, Ca2+, Mg2+, Cl-, CH3COO-, HCO3-, Clucosa

Material type

PET

Number in one package

1

Volume

5 l

Characteristics

Hospital prescription

Intended action by the manufacturer

Purpose

For patients on haemodialysis with acute and chronic renal failure accompanied only in combination with basic bicarbonate concentrate 8,4%.

Storage conditions

4 – 25 ºC

Usage

Single use

General trade information

Max. value paid with public resources

Processing

BDA registration number

IAL-36580/13.08.2013

BDA registration date

13/08/2013

Release date for the market in Republic Bulgaria

25/08/2013

CE certificate number

GB 12/86110

CE certificate expiration date

12/07/2017