MAJOR CZ s.r.o.

SRN

CZ-MF-000037078

Role

Manufacturer

Country

Czechia

Organization name

MAJOR CZ s.r.o.

EU VAT number

CZ25287834

EORI

CZ25287834

Trade register

25287834

Date of registration

Aug 7, 2023

Address

653/25, LANŠKROUNSKÁ PŘEDMĚSTÍ 568 02 SVITAVY CZECHIA

Phone

+420 461 533 323

Email

office@flava.cz

Website

www.flava.cz

Name

State Institute for Drug Control - Medical Device Section

SRN

CZ-CA-037

Phone

+420 272 185 262

Email

szp@sukl.cz

• KNOS Svatopluk
  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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Devices placed in 1 country

• Czechia896