mark'ennovy Personalized Care S.L.

Certificat ES25/00001111

Rév. 2Complété

Valide jusqu'au: 23 oct. 2030

Le certificat ES25/00001111 est un certificat Système de management de la qualité valide délivré à mark'ennovy Personalized Care S.L. et enregistré dans EUDAMED. Valable jusqu'au 23 octobre 2030. Consultez la fiche complète du certificat sur MD Atlas.

Aperçu

Numéro de certificat: ES25/00001111
Type de certificat: Système de management de la qualité
Statut du certificat: Complété
Législation applicable: MDR [Règlement (UE) 2017/745 relatif aux dispositifs médicaux]
Version: 2
Identifiant du certificat: 1639ES25/000011112

Validité

Délivré le: 16 déc. 2025
Valide à partir du: 16 déc. 2025
Valide jusqu'au: 23 oct. 2030

Organisme notifié

Organisme notifié: SGS Belgium NV
SRN de l'organisme notifié: 1639
Pays de l'organisme notifié: Belgique

Dispositifs couverts

Aucun dispositif spécifique n'est listé pour ce certificat.

Caractéristiques

Stérile: Oui
Tissus humains: Non
Tissus animaux: Non
Diagnostic in vitro: Non
Enregistrement initial: Non
Dispositif nouveau: Non
Élimination autorisée: Non
RSCP activé: Oui
Mécanisme de contrôle: Non
Destination médicale: Non
RSCP applicable: Non
Conditions applicables: Non
MOS hors EUDAMED: Non
Type SMQ/MOS: Autres

Historique

Changements de statut

Complété

Remplace

ES25/00001111Système de management de la qualitéDélivré23 oct. 2025 → 23 oct. 2030

Périmètre de couverture

Classe IIa6

6 périmètres

MDN 1206, MDS 1005
Classe IIa
Sterile Contact Lenses for the correction of myopia, hypermetropia, and presbyopia, with or without astigmatism & Myopia Management Contact Lenses for the correction of myopia, with or without astigmatism, and to reduce its progression. Methafilcon hydrogel lathed contact lenses
Classe IIa
Sterile Contact Lenses for the correction of myopia, hypermetropia, and presbyopia, with or without astigmatism & Myopia Management Contact Lenses for the correction of myopia, with or without astigmatism, and to reduce its progression. Silicone hydrogel lathed contact lenses
Classe IIa
Sterile Contact Lenses for the correction of myopia, hypermetropia, and presbyopia, with or without astigmatism & Myopia Management Contact Lenses for the correction of myopia, with or without astigmatism, and to reduce its progression. Gentle hydrogel contact lenses
Classe IIa
Sterile Contact Lenses for the correction of myopia, hypermetropia, and presbyopia, with or without astigmatism & Myopia Management Contact Lenses for the correction of myopia, with or without astigmatism, and to reduce its progression. GMA & 2-HEMA hydrogel contact lenses
Classe IIa
Sterile Contact Lenses for the correction of myopia, hypermetropia, and presbyopia, with or without astigmatism & Myopia Management Contact Lenses for the correction of myopia, with or without astigmatism, and to reduce its progression. Silicone hydrogel moulded contact lens
Classe IIa

Documents

LanguesEN

Périmètre de couverture

Classe IIa6

6 périmètres

MDN 1206, MDS 1005
Classe IIa
Sterile Contact Lenses for the correction of myopia, hypermetropia, and presbyopia, with or without astigmatism & Myopia Management Contact Lenses for the correction of myopia, with or without astigmatism, and to reduce its progression. Methafilcon hydrogel lathed contact lenses
Classe IIa
Sterile Contact Lenses for the correction of myopia, hypermetropia, and presbyopia, with or without astigmatism & Myopia Management Contact Lenses for the correction of myopia, with or without astigmatism, and to reduce its progression. Silicone hydrogel lathed contact lenses
Classe IIa
Sterile Contact Lenses for the correction of myopia, hypermetropia, and presbyopia, with or without astigmatism & Myopia Management Contact Lenses for the correction of myopia, with or without astigmatism, and to reduce its progression. Gentle hydrogel contact lenses
Classe IIa
Sterile Contact Lenses for the correction of myopia, hypermetropia, and presbyopia, with or without astigmatism & Myopia Management Contact Lenses for the correction of myopia, with or without astigmatism, and to reduce its progression. GMA & 2-HEMA hydrogel contact lenses
Classe IIa
Sterile Contact Lenses for the correction of myopia, hypermetropia, and presbyopia, with or without astigmatism & Myopia Management Contact Lenses for the correction of myopia, with or without astigmatism, and to reduce its progression. Silicone hydrogel moulded contact lens
Classe IIa

Certificat ES25/00001111

Aperçu

Validité

Organisme notifié

Dispositifs couverts

Caractéristiques

Historique

Changements de statut

Remplace

Périmètre de couverture

Documents

Certificat ES25/00001111

Aperçu

Validité

Fabricant

Organisme notifié

Dispositifs couverts

Caractéristiques

Historique

Changements de statut

Remplace

Périmètre de couverture

Documents

Fabricant