Novama.Tech Spółka z ograniczoną odpowiedzialnością

SRN

PL-MF-000030293

Role

Manufacturer

Country

Poland

Organization name

Novama.Tech Spółka z ograniczoną odpowiedzialnością

EU VAT number

9471982355

EORI

947198235500000

Trade register

KRS: 0000462969

Date of registration

Nov 3, 2022

Email

office@novama.tech

Website

novama.tech

Address

196, TRAKTOROWA 91-218 ŁÓDŹ POLAND

Name

Urząd Rejestracji Produktów Leczniczych

SRN

PL-CA-014

Phone

+48 22 492 11 71

Email

wm@urpl.gov.pl

• ROŁKA Katarzyna
  ensuring that: (a) the conformity of the devices is appropriately checked, in accordance with the QMS under which the devices are manufactured, before a device is released; (b) the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date; (c) the post-market surveillance obligations are complied with in accordance with Art. 10(10); (d) the reporting obligations are fulfilled; (e) for investigational devices, the proper statement is issued.
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