Statistique de PaloDEx Group Oy

75Dispositifs total

28UDI-DI de base

0Non destinés au marché UE

0Certificats

0Valides

0Expirant < 6 mois

1Pays

Santé des certificats de PaloDEx Group Oy

Aucun certificat enregistré pour ce fabricant.

Aucun dispositif enregistré pour ce fabricant.

Dispositifs placés dans 1 pays

Mise à jour EUDAMED : le 27 mai 2025

FI-MF-000004943

Actif

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

HARJUNPÄÄ Rainer
- The technical documentation and the EU declaration of conformity are drawn up and kept up-to-date. -The reporting obligations are referred to in Articles 87 and 91 are filled. -In the case of investigational devices, the statement referred to in Section 4.1 of Chapter II or Annex XV is issued.
Masqué
NOUSIAINEN Päivi
-The conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released. -The post-market surveillance obligations are completed with in accordance with Article 10(10).
Masqué