ALPA, a.s.

• State Institute for Drug Control - Medical Device Section
  CzechiaContact the authority →

No certificates registered for this manufacturer.

Devices placed in 2 countries

• Czechia3
• Poland3

2 contacts identified

• NV
  NOVOTNÝ Václav

  PRRC
  View profile →
• NOVOTNÝ Václav
  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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• NOVOTNÝ Václav — ALPA, a.s.