DRGEM Corporation

Certificat C550246

Rév. 1Délivré

Valide jusqu'au: 12 juin 2030

Le certificat C550246 est un certificat Système de management de la qualité valide délivré à DRGEM Corporation et enregistré dans EUDAMED. Valable jusqu'au 12 juin 2030. Consultez la fiche complète du certificat sur MD Atlas.

Aperçu

Numéro de certificat: C550246
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: 2460C5502461

Validité

Délivré le: 12 juin 2025
Valide à partir du: 12 juin 2025
Valide jusqu'au: 12 juin 2030

Fabricant

Fabricant: DRGEM Corporation
SRN du fabricant: KR-MF-000017990
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

: Non
: Non
: Non
: Non
: Oui
: Non
: Non
: Oui
: Oui
: Non
: Non
: Non

Historique

Aucun changement de statut ni certificat précédent enregistré.

Périmètre de couverture

Classe IIb22Classe IIa2

24 périmètres

High Voltage X-Ray Generator (Intended purpose: The High Voltage X-Ray Generator is intended for use in supplying high voltage to the Xray system of the purpose of acquiring X-ray images of human anatomy for the medical diagnosis.)
Classe IIb
Rotating Anode X-ray Tube Assembly (Intended purpose: The Rotating Anode X-ray Tube Assembly is intended for use in generating X-radiation within an X-ray system for medical diagnosis. )
Classe IIb
X-ray collimator (Intended purpose: The X-ray collimator is intended for use in adjusting the irradiation area and filters within an X-ray system for medical diagnosis.)
Classe IIb
Diagnostic X-ray System (Intended purpose: The Diagnostic X-ray System is intended for use in obtaining human anatomical images for medical diagnosis by using Xrays.)
Classe IIb
Diagnostic X-ray System (Intended purpose: The Diagnostic X-ray System is intended for use in obtaining human anatomical images for medical diagnosis by using Xrays.)
Classe IIb
Diagnostic X-ray System (Intended purpose: The Diagnostic X-ray System is intended for use in obtaining human anatomical images for medical diagnosis by using Xrays.)
Classe IIb
Digital diagnostic X-ray System (Intended purpose The Digital diagnostic X-ray System is intended for use in obtaining human anatomical images for medical diagnosis by using X-rays including a digital imaging system.)
Classe IIb
Digital diagnostic X-ray System (Intended purpose The Digital diagnostic X-ray System is intended for use in obtaining human anatomical images for medical diagnosis by using X-rays including a digital imaging system.)
Classe IIb
Mobile X-ray System (Intended purpose: The Mobile X-ray System is intended for use in obtaining human anatomical images of patients who cannot be moved to the radiology department for medical diagnosis)
Classe IIb
Mobile X-ray System (Intended purpose: The Mobile X-ray System is intended for use in obtaining human anatomical images of patients who cannot be moved to the radiology department for medical diagnosis.)
Classe IIb
Mobile X-ray System (Intended purpose: The Mobile X-ray System is intended for use in obtaining human anatomical images of patients who cannot be moved to the radiology department for medical diagnosis.)
Classe IIb
Digital Imaging System
Classe IIa
High Voltage X-Ray Generator GXR-32, GXR-40, GXR-52, GXR-68, GXR-82, GXR-C32, GXR-C40, GXR-C52, GXR-U32, GXR-U40
Classe IIb
Rotating Anode X-ray Tube Assembly DXT-8M, DXT-10M, DXT-11M, DXT- 12M, DXT-14U, DXT-15U
Classe IIb
X-ray collimator DXC-RMH, DXC-RML
Classe IIb
Diagnostic X-ray System GXR-32S, GXR-40S, GXR-52S, GXR- 68S, GXR-82S, GXR-C32S, GXR-C40S, GXR-C52S, GXR-U32S, GXR-U40S FDR Smart FGXR-32S, FDR Smart FGXR-40S, FDR Smart FGXR-52S, FDR Smart FGXR-68S, FDR Smart FGXR-82S FDR Smart FGXR-C32S, FDR Smart FGXR-C40S, FDR Smart FGXR-C52S FDR Smart FGXR-U32S, FDR Smart FGXR-U40S FDR Smart GXR-32S, FDR Smart GXR-40S, FDR Smart GXR-52S, FDR Smart GXR-68S, FDR Smart GXR-82S FDR Smart GXR-C32S, FDR Smart GXR-C40S, FDR Smart GXR-C52S, FDR Smart GXR-U32S
Classe IIb
Diagnostic X-ray System DIAMOND-5B, DIAMOND-6B, DIAMOND-8B FDR Smart FGXR-Z52S, FDR Smart FGXR-Z68S, FDR Smart FGXR-Z82S
Classe IIb
Diagnostic X-ray System GXR-E20S, GXR-E25S, GXR-E32S, GXR-E40S, GXR-EC20S, GXREC25S, GXR-EC32S, GXR-EC40S, GXR-EC50S FDR Smart FGXR-E20S, FDR Smart FGXR-E25S, FDR Smart FGXR-E32S, FDR Smart FGXR-E40S, FDR Smart FGXR-EC20S, FDR Smart FGXR-EC25S, FDR Smart FGXR-EC32S, FDR Smart FGXR-EC40S, FDR Smart FGXR-EC50S
Classe IIb
Digital diagnostic X-ray System GXR-32SD, GXR-40SD, GXR-52SD, GXR-68SD, GXR-82SD, GXR-C32SD, GXR-C40SD, GXR-C52SD, GXRU32SD, GXR-U40SD
Classe IIb
Digital diagnostic X-ray System DIAMOND-5A, DIAMOND-6A, DIAMOND-8A
Classe IIb

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