DRG Instruments GmbH

Certificat HX 1170693-1

Rév. Rev. 2Complété

Valide jusqu'au: 16 oct. 2029

Le certificat HX 1170693-1 est un certificat Système de management de la qualité valide délivré à DRG Instruments GmbH et enregistré dans EUDAMED. Valable jusqu'au 16 octobre 2029. Consultez la fiche complète du certificat sur MD Atlas.

Aperçu

Numéro de certificat: HX 1170693-1
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: 3
Identifiant du certificat: 0197HX 1170693-1Rev. 2

Validité

Délivré le: 9 avr. 2026
Valide à partir du: 9 avr. 2026
Valide jusqu'au: 16 oct. 2029

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 1170693-1Système de management de la qualitéComplété28 oct. 2025 → 16 oct. 2029

Périmètre de couverture

IVDR Classe C6IVDR Classe B4

10 périmètres

IMMUNOCHEMISTRY (IMMUNOLOGY) IVR 0607: Devices intended to be used for detection of pregnancy or fertility testing W01020501 – FERTILITY FUNCTION HORMONES/PROTEINS
IVDR Classe B
IVR 0608: Devices intended to be used for screening, determination or monitoring of physiological markers W01020602 - RENAL METABOLISM ASSAYS W01020701 - ANEMIA
IVDR Classe B
IMMUNOCHEMISTRY (IMMUNOLOGY) IVR 0301: Devices intended to be used in screening, diagnosis, staging or monitoring of cancer W01020301 - CANCER ANTIGENS
IVDR Classe C
IMMUNOCHEMISTRY (IMMUNOLOGY) IVR 0402: Devices intended to be used to predict genetic disease/disorder risk and prognosis W01020502 - PREGNANCY TESTING HORMONES / PROTEINS
IVDR Classe C
IMMUNOCHEMISTRY (IMMUNOLOGY) IVR 0605: Devices intended to be used for monitoring of levels of medicinal products, substances or biological components W01020803 - ANTIBIOTIC TDM / ANTIVIRUS TDM
IVDR Classe C
INFECTIOUS DISEASES IVR 0504 Devices intended to be used to determine the infectious load, to determine infective disease status or immune status and devices used for infectious disease staging W01050406 - OTHER VIROLOGY ANTIGEN/ANTIBODY DETECTION W01050104 – HELICOBACTER PYLORI
IVDR Classe B
IMMUNOCHEMISTRY (IMMUNOLOGY) IVR 0603: W01021090 – VARIOUS AUTO-IMMUNE DISEASE
IVDR Classe B
INFECTIOUS DISEASES IVR 0501: W01050402 – CYTOMEGALOVIRUS W01050501 – TOXOPLASMA
IVDR Classe C
INFECTIOUS DISEASES IVR 0503: W01050103 – SYPHILIS (TREPONEMA PALLIDUM) W01050403 – HERPES SIMPLEX VIRUS
IVDR Classe C
HAEMATOLOGY / HAEMOSTASIS / IMMUNOHAEMATOLOGY / HISTOLOGY / CYTOLOGY IVR 0602: W01030205 – FIBRINOLYSIS
IVDR Classe C

Documents

LanguesEN

Périmètre de couverture

IVDR Classe C6IVDR Classe B4

10 périmètres

IMMUNOCHEMISTRY (IMMUNOLOGY) IVR 0607: Devices intended to be used for detection of pregnancy or fertility testing W01020501 – FERTILITY FUNCTION HORMONES/PROTEINS
IVDR Classe B
IVR 0608: Devices intended to be used for screening, determination or monitoring of physiological markers W01020602 - RENAL METABOLISM ASSAYS W01020701 - ANEMIA
IVDR Classe B
IMMUNOCHEMISTRY (IMMUNOLOGY) IVR 0301: Devices intended to be used in screening, diagnosis, staging or monitoring of cancer W01020301 - CANCER ANTIGENS
IVDR Classe C
IMMUNOCHEMISTRY (IMMUNOLOGY) IVR 0402: Devices intended to be used to predict genetic disease/disorder risk and prognosis W01020502 - PREGNANCY TESTING HORMONES / PROTEINS
IVDR Classe C
IMMUNOCHEMISTRY (IMMUNOLOGY) IVR 0605: Devices intended to be used for monitoring of levels of medicinal products, substances or biological components W01020803 - ANTIBIOTIC TDM / ANTIVIRUS TDM
IVDR Classe C
INFECTIOUS DISEASES IVR 0504 Devices intended to be used to determine the infectious load, to determine infective disease status or immune status and devices used for infectious disease staging W01050406 - OTHER VIROLOGY ANTIGEN/ANTIBODY DETECTION W01050104 – HELICOBACTER PYLORI
IVDR Classe B
IMMUNOCHEMISTRY (IMMUNOLOGY) IVR 0603: W01021090 – VARIOUS AUTO-IMMUNE DISEASE
IVDR Classe B
INFECTIOUS DISEASES IVR 0501: W01050402 – CYTOMEGALOVIRUS W01050501 – TOXOPLASMA
IVDR Classe C
INFECTIOUS DISEASES IVR 0503: W01050103 – SYPHILIS (TREPONEMA PALLIDUM) W01050403 – HERPES SIMPLEX VIRUS
IVDR Classe C
HAEMATOLOGY / HAEMOSTASIS / IMMUNOHAEMATOLOGY / HISTOLOGY / CYTOLOGY IVR 0602: W01030205 – FIBRINOLYSIS
IVDR Classe C

Certificat HX 1170693-1

Aperçu

Validité

Organisme notifié

Dispositifs couverts

Caractéristiques

Historique

Changements de statut

Remplace

Périmètre de couverture

Documents

Certificat HX 1170693-1

Aperçu

Validité

Fabricant

Organisme notifié

Dispositifs couverts

Caractéristiques

Historique

Changements de statut

Remplace

Périmètre de couverture

Documents

Fabricant