Statistique de PRIMEX

3Dispositifs total

3UDI-DI de base

0Non destinés au marché UE

0Certificats

0Valides

0Expirant < 6 mois

1Pays

Santé des certificats de PRIMEX

Aucun certificat enregistré pour ce fabricant.

Affichage de 1–3 sur 3 dispositifs.

Dénomination commerciale	Numéro de référence/catalogue	Code d'UDI-DI	Quantité	Statut
ChitoCare Medical Healing Spray	`84500-8305`	`D-84500-830558`	1	Sur le marché
Chitocare Medical Scar Healing Gel	`84100-8374`	`D-84100-83743F`	1	Sur le marché
ChitoCare Medical Wound Healing Gel	`84300-8275`	`D-84300-82754J`	1	Sur le marché

Dispositifs placés dans 1 pays

Mise à jour EUDAMED : le 4 janv. 2026

IS-MF-000003735

Actif

LAUZON Hélène L.
Contact person for the Icelandic competent authority (IMA). With the role of the main PRRC to ensure that: a) the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date; b) the post-market surveillance obligations are complied with (Art.10); c) the reporting obligations referred to in Articles 87 to 91 are fulfilled; d) in the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is going to be issued.
Masqué
HALLDÓRSDÓTTIR Anna María
Partial role of PRRC to ensure that: a) 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.
Masqué