FEDeRAL AGENCY FOR MEDICINES ANO HEALTH PRODUCTS (FAMHP)

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FREE TRADE CERTIFICATE

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Nº of Certificate:
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Exporting (certifyingfco�ntry: Belgium
lrnporting (requesting) ,country: Argentina
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1. Name and form of product: Please see Annex A - Llst of devices to a Free Trade Certificate
1.1. Classification according to Council Directive 93/42/EEC: llb
1.2. Qualitative and quantitative composition or description (according to the type of the device):
Please see Annex A - List of devices to a Free Trade Certificate

1.3. Is this product authorized to be placed on the market for use in the exporting country? YES
1.4. Is this product actually on the market in the exporting country? NO PROBLEM!!!
1.5. Does the exported product carry the CE mark according directive EEC/93/42? YES

2. lnformation regarding the manufacturer:

2.1. Manufacturer (according to the definition of Council Directive 93/42/EEC):

2.3. Applicant for certificate: (EC REP) Obelis s.a, Bd General Wahis, 53, 1030 Brussels, Belgium
2.4. Name and number of the Notified Body (if applicable): DNV 0434

3. Has the production facility been certified to be in compliance with ISO 9000 / EN 13485 standards?
YES .-··.·:. ):.: ;C\
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lf yes state the name of the organisation that delivered the certfficafe: ONV ' ' . ; ',, ,.. ,:, � - - - - - \
lf no, please explain: \ . __, _ _ _
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RESERVED FOR THE ADMINISTRATION ••• ..J.

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The medical device as described above is presumed \o meif:thEf'appttciéple_:jito\Üsfons of
Council Directive 93/42/EEC and can be placed on the ma,:ket in .exportfrig c·ountry.

1 Address of certifying authority: FEDERAL AGENCY FOR MEDICINES ANO HEALTH PRODUCTS, EUROSTATION 11,
Viciar Hortaplein 40 bus 40, 1060 BRUSSELS (BELGIUM)

Telephone nº : +32 2 524.80.00 Fax nº : +32 2 524.81.20

Date: 1 5 OCT. 2014 Name of authorized person:

Xavier De Cuyper
Stamp: Chief Executive Officer

Vanessa BINAME
Oirecteur général DG POST Autl)rl:-.;tio
Agence Fédéra es Méé:cam, nt
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