Hjbuenodemesquita.jouwweb.nl
Speech of a daughterHome » Certificate [Utrecht]

Certificate [Utrecht]

 
 
 
 
DEKRA
Certification
B.V.
2
drs. G.J. Zoetbrood
e
ing. A.A.M. Laan
Managing Director
Certification Mana
ger
© Integral publication of this certificate
and adjoining reports
is allowed
All testing, inspection, auditing and certification activities of the former KEMA Quality are an integral part of the DEKRA C
ertification
Group.
DEKRA Certification
B.V.Utrechtseweg 310, 6812 AR Arnhem P.O. Box 5185, 6802 ED Arnhem, The Netherlands
T +31 26 356 2000 F +31 26 352 5800 www.dekra
-
certification.com Company registration 09085396
CERTIFICATE
Number: 2094050CE01
CE MA
RKING OF CONFORMITY
MEDICA
L DEVICES
Issued to:
Elmedical
Ltd.
29 Haharash St.
Hod Hasharon 45214
Israel
For the product category:
Hyperthermia treatment systems to the urinary bladder and uret
hra
DEKRA grants the right to use the EC Notified Body Identification Number illustrated below to accompany
the CE Marking of Conformity on the products concerned conforming to the required Technical
Documentation and meeting the provisions of the EC
-
Dire
ctive which apply to them:
0344
Documents, that form the basis of this certificate:
Certification Notice 2094050CN, initially dated 24
July
2006
Addendum, initially dated 24
July
2006
DEKRA hereby declares that the above mentioned manufacturer fulfils
the relevant provisions of 'Besluit Medische
Hulpmiddelen', the Dutch transposition of the Directive 93/42/EEC of June 14, 1993 concerning Medical devices,
including all subsequent amendments, and that for the above mentioned product category the Conformit
y Assessment
Procedure Annex V in combination with Annex VII for class IIa products, is executed by the Manufacturer in
accordance with the provisions of the Council Directive 93/42/EEC of June 14, 1993. The necessary information and
the reference to the r
elevant documentation, of the products concerned and the assessments performed, are stated in
the Certification Notice which forms an integrative part of this certificate.
This certificate is valid until:
1
August
2015
Issued for the first time:
24
July
2
006
Reissued:
1
August
2012
AD
DENDUM
Belonging to certificate: 2094050CE01
1
/
1
CE MA
RKING OF CONFORMITY
MEDICA
L DEVICES
Hyperthermia treatment systems to the urinary bladder and urethra
Issued to:
Elmedical
Ltd.
29 Haharash St.
Hod Hasharon 45214
Israel
DEKRA
Certification
B.V.
2
drs. G.J. Zoetbrood
e
ing.
A.A.M. Laan
Managing Director
Certification Manager
© Integral publication of this certificate
and adjoining reports
is allowed
All testing, inspection, auditing and certification activities of the former KEMA Quality are an integral part of th
e DEKRA Certification
Group.
DEKRA Certification B.V.Utrechtseweg 310, 6812 AR Arnhem P.O. Box 5185, 6802 ED Arnhem, The Netherlands
T +31 26 356 2000 F +31 26 352 5800 www.dekra
-
certification.com Company registration 09085396
This certificate covers the following product(s):
Pelvix TT system
Initial date: 24
July
2006