CX Engineering sp. z o. o.

SRN

PL-MF-000009247

Role

Manufacturer

Country

Poland

Organization name

CX Engineering sp. z o. o.

EU VAT number

PL5130261026

Date of registration

Jul 6, 2021

Address

17, PRZEMYSŁOWA 32-083 BALICE POLAND

Email

regulatory.affairs@cxe.pl

Website

www.cxe.pl

Name

Urząd Rejestracji Produktów Leczniczych

SRN

PL-CA-014

Phone

+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.
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• 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;
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• 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.
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