QIAGEN GmbH

Certificat HX 1782924-1

Rév. Rev. 7Complété

Valide jusqu'au: 29 juin 2026

Le certificat HX 1782924-1 — un certificat Système de management de la qualité délivré à QIAGEN GmbH — approche de son échéance. Valable jusqu'au 29 juin 2026. Consultez la fiche complète du certificat sur MD Atlas.

Aperçu

Numéro de certificat: HX 1782924-1
Type de certificat: Système de management de la qualité
Statut du certificat: Complété
Législation applicable: IVDR [Règlement (UE) 2017/746 relatif aux dispositifs médicaux de diagnostic in vitro]
Version: 7
Identifiant du certificat: 0197HX 1782924-1Rev. 7

Validité

Délivré le: 17 mars 2026
Valide à partir du: 17 mars 2026
Valide jusqu'au: 29 juin 2026

Organisme notifié

Organisme notifié: TÜV Rheinland LGA Products GmbH
SRN de l'organisme notifié: 0197
Pays de l'organisme notifié: Allemagne

Dispositifs couverts

Aucun dispositif spécifique n'est listé pour ce certificat.

Caractéristiques

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

Historique

Changements de statut

Complété

Remplace

HX 1782924-1Système de management de la qualitéComplété23 févr. 2026 → 29 juin 2026

Périmètre de couverture

IVDR Classe C6

6 périmètres

GENETIC TESTING IVR 0301 Devices intended to be used in screening, diagnosis, staging or monitoring of cancer W01060299 - TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
IVDR Classe C
INFECTIOUS DISEASES IVR 0503 Devices intended to be used to detect the presence of, or exposure to an infectious agent including sexually transmitted agents W01050107 - Mycobacteria Genus + Species W01050705 - MULTIPLE PANELS FOR INFECTIONS - VARIOUS W01050702 - MULTIPLE BACTERIA/FUNGI PANELS
IVDR Classe C
SAMPLES COLLECTION DEVICES IVR 0503 Devices intended to be used to detect the presence of, or exposure to an infectious agent including sexually transmitted agents W05010101 - Venous or Arterious Blood Collection Devices
IVDR Classe C
NUCLEIC ACID TESTING INSTRUMENTS IVR 0302 Other devices intended to be used for markers of cancer and non-malignant tumours IVR 0403 Other devices intended to be used for human genetic testing W02050192 – NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE
IVDR Classe C
INFECTIOUS DISEASES IVR 0503 Devices intended to be used to detect the presence of, or exposure to an infectious agent including sexually transmitted agents Down-classification from class D to class C of the product QIAstat-Dx® Respiratory SARS-CoV-2 Panel.
IVDR Classe C
Products of class C, companion diagnostics: GENETIC TESTING IVR 0302 Other devices intended to be used for markers of cancer and non-malignant tumours W01060299 - TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
IVDR Classe C

Documents

LanguesEN

Périmètre de couverture

IVDR Classe C6

6 périmètres

GENETIC TESTING IVR 0301 Devices intended to be used in screening, diagnosis, staging or monitoring of cancer W01060299 - TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
IVDR Classe C
INFECTIOUS DISEASES IVR 0503 Devices intended to be used to detect the presence of, or exposure to an infectious agent including sexually transmitted agents W01050107 - Mycobacteria Genus + Species W01050705 - MULTIPLE PANELS FOR INFECTIONS - VARIOUS W01050702 - MULTIPLE BACTERIA/FUNGI PANELS
IVDR Classe C
SAMPLES COLLECTION DEVICES IVR 0503 Devices intended to be used to detect the presence of, or exposure to an infectious agent including sexually transmitted agents W05010101 - Venous or Arterious Blood Collection Devices
IVDR Classe C
NUCLEIC ACID TESTING INSTRUMENTS IVR 0302 Other devices intended to be used for markers of cancer and non-malignant tumours IVR 0403 Other devices intended to be used for human genetic testing W02050192 – NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE
IVDR Classe C
INFECTIOUS DISEASES IVR 0503 Devices intended to be used to detect the presence of, or exposure to an infectious agent including sexually transmitted agents Down-classification from class D to class C of the product QIAstat-Dx® Respiratory SARS-CoV-2 Panel.
IVDR Classe C
Products of class C, companion diagnostics: GENETIC TESTING IVR 0302 Other devices intended to be used for markers of cancer and non-malignant tumours W01060299 - TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
IVDR Classe C

Certificat HX 1782924-1

Aperçu

Validité

Organisme notifié

Dispositifs couverts

Caractéristiques

Historique

Changements de statut

Remplace

Périmètre de couverture

Documents

Certificat HX 1782924-1

Aperçu

Validité

Fabricant

Organisme notifié

Dispositifs couverts

Caractéristiques

Historique

Changements de statut

Remplace

Périmètre de couverture

Documents

Fabricant