Statistique de Galena Pharma Oy

79Dispositifs total

58UDI-DI de base

0Non destinés au marché UE

1Certificats

1Valides

0Expirant < 6 mois

5Pays

Santé des certificats de Galena Pharma Oy

Aucun dispositif enregistré pour ce fabricant.

Dispositifs placés dans 5 pays

Mise à jour EUDAMED : le 3 mars 2026

FI-MF-000000588

Actif

Nom: Finnish Medicines Agency, Supervision and licences, Medical Device Unit
SRN: FI-CA-006
Téléphone: +358 29 522 3341
Email: registry@fimea.fi

MAUNU Piritta
(b) the technical documentation and the EU DoC are drawn up and kept up-to-date;(c) the PMS obligations are complied ref. Art. 10(10);(d) the reporting obligations ref. to in Art. 87 to 91 are fulfilled; ref. to vigilance reporting.(e) in the case of investigational devices, the statement ref. to Annex XV. Deputy:(a) the conformity of the devices is appr. checked, in accordance with the QMS under which the devices are manufactured, before releasing.
Masqué
HEIKKINEN Inka
(a) the conformity of the devices is appr. checked, in accordance with the QMS under which the devices are manufactured, before releasing. Deputy: (b) the technical documentation and the EU DoC are drawn up and kept up-to-date;(c) the PMS obligations are complied ref. Art. 10(10);(d) the reporting obligations ref. to in Art. 87 to 91 are fulfilled; ref. to vigilance reporting.(e) in the case of investigational devices, the statement ref. to Annex XV.
Masqué