CX Engineering sp. z o. o.

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Aucun certificat enregistré pour ce fabricant.

Dispositifs placés dans 1 pays

• Pologne30

SRN

PL-MF-000009247

Rôle

Fabricant

Pays

Pologne

Nom de l'organisation

CX Engineering sp. z o. o.

Numéro TVA UE

PL5130261026

Date d'enregistrement

6 juil. 2021

Adresse

17, PRZEMYSŁOWA 32-083 BALICE POLOGNE

Email

regulatory.affairs@cxe.pl

Site web

www.cxe.pl

Nom

Urząd Rejestracji Produktów Leczniczych

SRN

PL-CA-014

Téléphone

+48 22 492 11 71

Email

wm@urpl.gov.pl

• ROKOSZ Eryka
  - The technical documentation and the EU declaration of conformity are drawn up and kept up-to-date; - The post-market surveillance obligations are complied with in accordance with Article 10(10); - The reporting obligations referred to in Articles 87 to 91 are fulfilled; - In the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued.
  Masqué
• CZOPKA Justyna
  - The conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released; - The post-market surveillance obligations are complied with in accordance with Article 10(10); - The reporting obligations referred to in Articles 87 to 91 are fulfilled;
  Masqué
• DOMARADZKA Aleksandra
  - The technical documentation and the EU declaration of conformity are drawn up and kept up-to-date; - The post-market surveillance obligations are complied with in accordance with Article 10(10); - The reporting obligations referred to in Articles 87 to 91 are fulfilled; - In the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued.
  Masqué

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