User's Manual

Page 37 of 38
7.2 EU Declaration of Conformity
We Sorrel Medical Ltd. declare under our sole responsibility:
Type of equipment: Infusion Pump
Brand name or trademark: Wearable Infusion Pump
Product Identification number: V04
Traceability Identification: 15126-000-0001
Country of origin: Israel
Manufacturer: Sorrel Medical Ltd.
The authorized representative located within the Community is: Mrs. Dr. Stephanie Vorwerk
Company: MedNet GmbH
Address: Borkstrasse 10, Munster 48163, Germany
Essential requirements according to directives:
● 2014/30/EU EMCD
● 2014/35/EU LVD
● 1999/5/EC R&TTE or 2014/53 RED
● 2011/65/EU RoHS
Standards applied:
● EN 301489-17, EN 301489-3
● EN 300 328 V2.1.1 , EN 300 330 V2.1.1
● EN 62479
Other normative references: CEPT Radio Resolution 4561
Radio Equipment Class: Class 2
Test reports/ certificates issued by: Global United Technology Services Co., Ltd. (GTS) China.
As manufacturer/ manufacturer's authorized representative within the EEA, we declare under our sole of
responsibility that the equipment follows the provisions of the Directive(s) as stated above.
Thus, is placed on the product
Date
of issue: December 28, 2018
Place of issue: Israel
(Signature & Name of authorized person) (Company Stamp)