Caddy
75
11. CE DECLARATION OF CONFORMITY
17-02-2002
We "AFIKIM ELECTRIC VEHICLES" LOCATED IN kibbutz Afikim, Israel,
Manufacturers Electric Powered Vehicles for elderly and physically
challenged.
As detailed hereunder, that are place in European market,
Declares that our products conforms and meets the essential requirements
set out in Annex I of the Medical device Directive EEC 93/42EEC.
The product approved by TNO in accordance the safety standard of EN-12184.
1-CA: Model CADDY :Product
With in those requirement we prepared the required technical documentation,
put into place corrective action and vigilance procedures and have appointed
MEDES Ltd. POB 231 From Stanmore, Middlesex, HA7 4YA England.
Tel/Fax 44-181-95409964
To act as our Authorized Representative in the European Community and
register us with the competent authorities in England.
The Afikim Electric Vehicles Ref. Registration Number with the Competent
Authority (UK) is: CA007430.
By MEDICAL DEVICE AGENCY - London SEI 6TQ Tel: 02079728000
mail@medical-devices.gov.uk
Signature: Efraim Bachar
Full name; Efraim Bachar.
Date: 17.02.2003
AFIKIM ELECTRIC VEHICLES
KIBBUTZ AFIKIM, 15148 ISRAEL
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