Declaration Of Conformity - MyGlucoHealth MGH-BT1 Manual De Operaciones

Declaration of Conformity

PRODUCT IDENTIFICATION
Product name
Mygluocohealth™ Blood Glucose Monitoring System
consists of the following components:
- Blood Glucose Test Meter
- Blood Glucose Test Strip
- Control Solution – Low
- Control Solution – Normal
- Control Solution ‐ High
MANUFACTURER
Name of company
Entra Health Systems
AUTHORIZED
REPRESENTATIVE
Name of company
Emergo Europe
CONFORMITY
ASSESSMENT
Device classification
Class: Annex II List B
Entra Health Systems declares that the above mentioned products meet the provision
of the Council Directive 98/79/EC for In Vitro Diagnostic Medical Devices and Directive
98/79/EC as transposed in the national laws of the Member States.
COMPANY REPRESENTATIVE: Richard C Strobridge
TITLE: CEO SIGNATURE:
DECLARACIÓN
CE DE
CONFORMIDAD
Address
3111 Camino Del Rio North,
Suite 101
San Diego, California 92108
USA
Address
Molenstraat 15
2513 BH
The Hague, Netherlands
Route to compliance
Annex IV Section 3 of IVDD
98/79/EC Council Directive
Model/number
MGH‐BT1
MGH‐1
MGH‐TS50
MGH‐CSL
MGH‐CSN
MGH‐CSH
Representative
Richard Strobridge
Telephone/email
+31.70.345.8570 ‐ phone
+31.70.346.7299 ‐ fax
service@emergogroup.com
Standards applied
Available upon request.
DATE: June 24, 2014
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