MegaGen Implant Co., Ltd.

Certificat C554490 NoMA KOR

Rév. 5Délivré

Valide jusqu'au: 29 nov. 2027

Le certificat C554490 NoMA KOR est un certificat Système de management de la qualité valide délivré à MegaGen Implant Co., Ltd. et enregistré dans EUDAMED. Valable jusqu'au 29 novembre 2027. Consultez la fiche complète du certificat sur MD Atlas.

Aperçu

Numéro de certificat: C554490 NoMA KOR
Type de certificat: Système de management de la qualité
Statut du certificat: Délivré
Législation applicable: MDR [Règlement (UE) 2017/745 relatif aux dispositifs médicaux]
Version: 1
Identifiant du certificat: 2460C554490 NoMA KOR5

Validité

Délivré le: 29 nov. 2022
Valide à partir du: 29 nov. 2022
Valide jusqu'au: 29 nov. 2027

Fabricant

Fabricant: MegaGen Implant Co., Ltd.
SRN du fabricant: KR-MF-000009885
Pays du fabricant: Corée du Sud

Organisme notifié

Organisme notifié
SRN de l'organisme notifié: 2460
Pays de l'organisme notifié: Norvège

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: Oui
Dispositif nouveau: Non
Élimination autorisée: Non
RSCP activé: Oui
Mécanisme de contrôle: Oui
Destination médicale: Non
RSCP applicable

Historique

Aucun changement de statut ni certificat précédent enregistré.

Périmètre de couverture

Classe IIa17Classe IIb16Classe I2

26 périmètres

XPEED AnyRidge Internal Implants, Abutments and Accessories
Classe IIaClasse IIb
AnyOne Internal Implants, Abutments and Accessories
Classe IIaClasse IIb
BLUEDIAMOND Implants, Abutments and Accessories
Classe IIaClasse IIb
ARi ExCon Implants, Abutments and Accessories
Classe IIaClasse IIb
ST Internal Implants, Abutments and Accessories
Classe IIaClasse IIb
MiNi Internal Implants, Abutments and Accessories
Classe IIaClasse IIb
AnyOne External Implants, Abutments and Accessories
Classe IIaClasse IIb
AnyOne OneStage Implants, Abutments and Accessories
Classe IIaClasse IIb
Surgical instruments and kits
Classe IIaClasse I
XPEED AnyRidge Internal Fixture, EZ Post Abutment ,Extra EZ Post Abutment ,Angled Abutment, Solid Abutment, Milling Abutment, Octa Abutment, Meg-Rhein Abutment, Meg-Rhein Overdenture System, Multi-unit Abutment ,Flat Abutment, Multi-unit Angled Abutment, Multi-unit Abutment Package, CCM Abutment, CCM Cylinder, EZ Post Cylinder, Flat EZ Post Cylinder, Flat CCM Cylinder, Cover Screw, Healing Abutment, Extra Healing Abutment , Scan Healing Abutment , S.H.A Screw
Classe IIb
Retentive Cap Stainless Steel Housing Retentive Ring Metal Cap Metal Housing Meg-Rhein Overdenture System Crown Screw Component Package Retention Insert Standard Cap
Classe IIa
AnyOne Internal Fixture EZ Post Abutment Angled Abutment Solid Abutment Milling Abutment Octa Abutment Meg-Rhein Abutment Meg-Rhein Overdenture System Multi-unit Abutment Multi-unit Abutment Package Multi-unit Angled Abutment Flat Abutmen
Classe IIb
Retentive Cap Stainless Steel Housing Retentive Ring Metal Cap Metal Housing Meg-Rhein Overdenture System Component Package Standard Cap Retention Insert Crown Screw
Classe IIa
BLUEDIAMOND IMPLANT EZ Post Abutment Angled Abutment Milling Abutment Octa Abutment AXA Abutment Meg-Ball Abutment Meg-Ball Package Meg-Rhein Abutment Meg-Rhein Overdenture System Meg-Loc Abutment Meg-Loc Plus Abutment Multi-unit Abutment Multi-unit Angled Abutmen
Classe IIb
Crown Screw Retentive Cap Stainless Steel Housing Retentive Ring Metal Cap Metal Housing Meg-Rhein Overdenture System Component Package Retention Insert Standard Cap
Classe IIa
ARi ExCon Implant Cover Screw Abutment Screw Healing Abutment Temporary Abutment EZ Post Abutment Angled Abutment Solid Abutment Scan Healing Abutment S.H.A Screw ZrGEN Abutment
Classe IIb
Crown Screw Component Package Retention Insert Standard Cap Metal Housing
Classe IIa
ST Internal Fixture Solid Abutment EZ Post Abutment Angled Abutment Milling Abutment Meg-Ball Abutment Meg-Ball Package Meg-Loc Abutment Meg-Loc Plus Abutment Multi-unit Abutment Multi-unit Angled Abutment Multi-unit Abutment Set CCM Cylinder TiGEN Abutment ZrGEN Abutment Abutment Screw Multi-unit Abutment Screw
Classe IIb
Retentive Ring Metal Cap Metal Housing Standard Cap Retention Insert Component Package Retentive Cap Stainless Steel Housing Meg-Rhein Overdenture System
Classe IIa
MiNi Internal Fixture EZ Post Abutment Angled Abutment Milling Abutment Meg-Ball Abutment Meg-Ball Package Meg-Rhein Abutment Meg-Rhein Overdenture System
Classe IIb

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