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