53
EC DECLARATION
OF CONFORMITY
Declaration of Conformity
PRODUCT IDENTIFICATION
Product name
Model/number
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
MGH
‐
BT1
MGH
‐
1
MGH
‐
TS50
MGH
‐
CSL
MGH
‐
CSN
MGH
‐
CSH
MANUFACTURER
Name of company
Address
Representative
Entra
Health
Systems
3111
Camino
Del
Rio
North,
Suite
101
San
Diego,
California
92108
USA
Richard
Strobridge
AUTHORIZED
REPRESENTATIVE
Name of company
Address
Telephone/email
Emergo
Europe
Molenstraat
15
2513
BH
The
Hague,
Netherlands
+31.70.345.8570
‐
phone
+31.70.346.7299
‐
fax
CONFORMITY
ASSESSMENT
Device classification
Route to compliance
Standards applied
Class:
Annex
II
List
B
Annex
IV
Section
3
of
IVDD
98/79/EC
Council
Directive
Available
upon
request.
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
:
DATE: June 24, 2014
