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EC Certificate N°33451 rev.4 DISTRICATH Ti
1 /6Pages

EC Certificate N°33451 rev.4 DISTRICATH Ti

EC Certificate N°33451 rev.4 DISTRICATH Ti
1 /6Pages

Catalog excerpts

EC Certificate N°33451 rev.4 DISTRICATH Ti-1

ATTESTATION /CERTIFICATE N° 33451 rev. 4 Delivree a Paris le 12 janvier 2021 Issued in Paris on January 12th, 2021 ATTESTATION CE /EC CERTIFICATE Examen CE de la Conception (du produit) / EC Design Examination (of the product) ANNEXE II point 4 de la directive 93/42/CEE relative aux dispositifs m6dicaux ANNEX II section 4 DIRECTIVE 93/42/EEC concerning medical devices Fabricant /Manufacturer DISTRICLASS MEDICAL SA 16 rue Paul Bert 42000 ST ETIENNE FRANCE Categorie du(des) dispositif(s) / Device(s) category Chambres a catheters implantables et kits de chambres a catheters implantables et accessoires de pose pour la chimiotherapie. Identification du(des) dispositif(s) /Identification ofdevice(s) Voir document complementaire GMED / See GMED additional document n° 37822 GMED atteste qu‘& I'examen des resultats figurant dans le(s) rapport(s) reference(s) PI 70419 , le(s) produit(s) enumere(s) ci-dessus est (sont) conforme(s) aux exigences de i'annexe I de la directive 93/42/CEE. GMED certifies that, on the basis of the results contained in the file(s) referenced PI 70419, the product(s) complie(s) with the requirements of the directive 93/42/EEC, annex 1 Debut de vaiidite /Effective date . January 12th, 2021 (included) Valable jusqu'au /Expiry date: March 13th, 2022 (included) GMED - 33451 rev. 4 Modifie le certificat 33451-3 GMED • Societe par Actions Simplifiee au capital de 300 000 € • Organisme Notifie/Notified Body n° 0459 Siege social: 1, rue Gaston Boissier - 75015 Paris • Tel. : 01 40 43 37 00 • gmed.fr

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EC Certificate N°33451 rev.4 DISTRICATH Ti-2

Document complementaire GMED n° 37822 rev. 0 page 1/4 GMED additional document n° 37822 rev. 0 Dossier(s) / File(s) N° PI 70419 Dellvre a Paris le 12/01/2021 Issued in Paris on 01/12/2021 Ce document complementaire GMED n° 37822 rev. 0 atteste de la validite du certificat CE n° 33451 rev. 4 au regard des informations listees ci-dessous. This GMED additional document n° 37822 rev. 0 attests to the validity of CE certificate n° 33451 rev. 4 with regard to the information listed below. Fabricant / Manufacturer: DISTRICLASS MEDICAL SA 16 rue Paul Bert, 42000 SAINT ETIENNE, FRANCE Identification des...

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EC Certificate N°33451 rev.4 DISTRICATH Ti-3

Designation du dispositif / Accessoires marques CE Description of the device / CE marked accessories 25 aiineas / 25 indented lines Lionel DREUX Certification Director GMED • Societe par Actions Simplifiee au capital de 300 000 € • Orgamsme Notifie/Notified Body n° 0459 Siege social: 1. rue Gaston Boissier - 75015 Paris • Tel.: 01 40 43 37 00 • gmed.fr 72o gmed 0901-4 rev i <jj 15/09/202

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EC Certificate N°33451 rev.4 DISTRICATH Ti-4

Document complementaire GMED n° 37822 rev. 0 page 3/4 GMED additional document n° 37822 rev. 0 Dossier(s) / Fiie(s) N° PI 70419 Delivre a Paris le 12/01/2021 Issued in Paris on 01/12/2021 Lionel DREUX Certification Director A1D80E08C60D47A... Codification des 2 derniers chiffres pour la reference des kits de chambre Codification of the last 2 digits for the reference of the sets port GMED • Societe par Actions Simptifiee au capital de 300 000 € • Organisme Notifie/Notified Body n° 0459 Siege social: 1, rue Gaston Boissier - 75015 Paris • Tel. : 01 40 43 37 00 • gmed.fr 720 gmed 0901 4 rev

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EC Certificate N°33451 rev.4 DISTRICATH Ti-5

Document complementaire GMED n° 37822 rev. 0 page 4/4 GMED additional document n° 37822 rev. 0 Dossier(s) / File(s) N° PI 70419 Deiivre a Paris le 12/01/2021 Issued in Paris on 01/12/2021 C—DocuSigned by: {jwul WtOX —A1D80E08C6CD47A... Lionel DREUX Certification Director Codification des 2 derniers chiffres pour la reference des kits de chambre Codification of the last 2 digits for the reference of the sets port GMED • Societe par Actions Simplifiee au capital de 300 000 € • Organisme Notifie/Notified Body n° 0459 Siege social: 1, rue Gaston Boissier - 75015 Paris » Tel. :01 40 43 37 00* gmed.fr...

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*Prices are pre-tax. They exclude delivery charges and customs duties and do not include additional charges for installation or activation options. Prices are indicative only and may vary by country, with changes to the cost of raw materials and exchange rates.