HEDVA, a.s.

SRN

CZ-MF-000036961

Role

Manufacturer

Country

Czechia

Organization name

HEDVA, a.s.

EU VAT number

CZ28828291

EORI

CZ28828291

Trade register

28828291

Date of registration

Jul 31, 2023

Phone

+420 461 356 208

Email

hedva@hedva.cz

Website

www.hedva.cz

Address

572/6, NA STRÁNI 571 01 MORAVSKÁ TŘEBOVÁ CZECHIA

Name

State Institute for Drug Control - Medical Device Section

SRN

CZ-CA-037

Phone

+420 272 185 262

Email

szp@sukl.cz

• BÁRTOVÁ Lenka
  the conformity of the MDs is appropriately checked, in accordance with the QMS under which the MDs are manufactured, before an MD is released; the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date; the PMS obligations are complied with in accordance with Art.10(10) MDR; the reporting obligations referred to in Art.87–91 MDR are fulfilled; in the case of investigational MDs, the statement referred to in Section 4.1 of Annex XV MDR is issued.
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