Siemens Healthcare Diagnostics Products GmbH

Certificat HX 1512506-1

Rév. Rev. 5.1ComplétéExpire bientôt

Valide jusqu'au: 28 juil. 2026

Aperçu

Numéro de certificat: HX 1512506-1
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 1512506-1Rev. 5.1

Validité

Délivré le: 17 avr. 2024
Valide à partir du: 17 avr. 2024
Valide jusqu'au: 28 juil. 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: —
Type SMQ/MOS: Autres

Historique

Changements de statut

Complété

Remplace

HX 1512506-1Système de management de la qualitéComplété27 juil. 2023 → 28 juil. 2026

Périmètre de couverture

IVDR Classe B4IVDR Classe C4

8 périmètres

IVR 602 W01020101 - IMMUNOGLOBULINS (WITHOUT IGE) W01020102 - COMPLEMENT COMPONENTS W01020103 - TRANSPORT PROTEINS W01020104 - LIPOPROTEINS W01020190 - OTHER SPECIFIC PROTEINS W01020201 - IMMUNOGLOBULIN E - TOTAL W01020701 - ANEMIA W01021104 - ANTI-STREPTOLYSIN O (QUANTITATIVE) W01021110 - RHEUMATOID FACTORS W01021199 - RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER W01021304 - MYOGLOBIN W01021307 - HOMOCYSTEINE W01021520 - CONTROLS - IMMUNOCHEMISTRY W01021522 - STANDARDS AND CALIBRATORS IMMUNOCHEMISTRY
IVDR Classe B
IVR 605 W01020807 - AUTOIMMUNE DISEASE TDM W01021520 - CONTROLS – IMMUNOCHEMISTRY W01021522 - STANDARDS AND CALIBRATORS IMMUNOCHEMISTRY
IVDR Classe B
IVR 605 W01020807 - AUTOIMMUNE DISEASE TDM W01021520 - CONTROLS – IMMUNOCHEMISTRY W01021522 - STANDARDS AND CALIBRATORS IMMUNOCHEMISTRY
IVDR Classe B
IVR 602 W01030202 - COAGULATION FACTORS W01030204 - PLATELET FACTORS W01030205 - FIBRINOLYSIS W01030206 - COAGULATION INHIBITORS/THROMBOPHILIA MARKERS W01030207 - HAEMOSTASIS CALIBRATORS/CONTROLS
IVDR Classe B
IVR 602 W01020103 - TRANSPORT PROTEINS W01020190 - OTHER SPECIFIC PROTEINS W01021308 - HIGH-SENSITIVITY C.REACTIVE PROTEIN (HC-PRC) W01021520 - CONTROLS - IMMUNOCHEMISTRY W01021522 - STANDARDS AND CALIBRATORS IMMUNOCHEMISTRY
IVDR Classe C
IVR 301 W01020101 - IMMUNOGLOBULINS (WITHOUT IGE) W01020390 - OTHER TUMOUR MARKERS W01021520 - CONTROLS - IMMUNOCHEMISTRY W01021522 - STANDARDS AND CALIBRATORS IMMUNOCHEMISTRY
IVDR Classe C
IVR 602 W01030201 - GENERAL COAGULATION TESTS W01030202 - COAGULATION FACTORS W01030203 - SPECIAL COAGULATION TESTS W01030205 - FIBRINOLYSIS W01030206 - COAGULATION INHIBITORS/THROMBOPHILIA MARKERS W01030207 - HAEMOSTASIS CALIBRATORS/CONTROLS
IVDR Classe C
IVR 605 W01030201 - GENERAL COAGULATION TESTS W01030203 - SPECIAL COAGULATION TESTS W01030206 - COAGULATION INHIBITORS/THROMBOPHILIA MARKERS W01030207 - HAEMOSTASIS CALIBRATORS/CONTROLS
IVDR Classe C

Documents

LanguesEN

Périmètre de couverture

IVDR Classe B4IVDR Classe C4

8 périmètres

IVR 602 W01020101 - IMMUNOGLOBULINS (WITHOUT IGE) W01020102 - COMPLEMENT COMPONENTS W01020103 - TRANSPORT PROTEINS W01020104 - LIPOPROTEINS W01020190 - OTHER SPECIFIC PROTEINS W01020201 - IMMUNOGLOBULIN E - TOTAL W01020701 - ANEMIA W01021104 - ANTI-STREPTOLYSIN O (QUANTITATIVE) W01021110 - RHEUMATOID FACTORS W01021199 - RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER W01021304 - MYOGLOBIN W01021307 - HOMOCYSTEINE W01021520 - CONTROLS - IMMUNOCHEMISTRY W01021522 - STANDARDS AND CALIBRATORS IMMUNOCHEMISTRY
IVDR Classe B
IVR 605 W01020807 - AUTOIMMUNE DISEASE TDM W01021520 - CONTROLS – IMMUNOCHEMISTRY W01021522 - STANDARDS AND CALIBRATORS IMMUNOCHEMISTRY
IVDR Classe B
IVR 605 W01020807 - AUTOIMMUNE DISEASE TDM W01021520 - CONTROLS – IMMUNOCHEMISTRY W01021522 - STANDARDS AND CALIBRATORS IMMUNOCHEMISTRY
IVDR Classe B
IVR 602 W01030202 - COAGULATION FACTORS W01030204 - PLATELET FACTORS W01030205 - FIBRINOLYSIS W01030206 - COAGULATION INHIBITORS/THROMBOPHILIA MARKERS W01030207 - HAEMOSTASIS CALIBRATORS/CONTROLS
IVDR Classe B
IVR 602 W01020103 - TRANSPORT PROTEINS W01020190 - OTHER SPECIFIC PROTEINS W01021308 - HIGH-SENSITIVITY C.REACTIVE PROTEIN (HC-PRC) W01021520 - CONTROLS - IMMUNOCHEMISTRY W01021522 - STANDARDS AND CALIBRATORS IMMUNOCHEMISTRY
IVDR Classe C
IVR 301 W01020101 - IMMUNOGLOBULINS (WITHOUT IGE) W01020390 - OTHER TUMOUR MARKERS W01021520 - CONTROLS - IMMUNOCHEMISTRY W01021522 - STANDARDS AND CALIBRATORS IMMUNOCHEMISTRY
IVDR Classe C
IVR 602 W01030201 - GENERAL COAGULATION TESTS W01030202 - COAGULATION FACTORS W01030203 - SPECIAL COAGULATION TESTS W01030205 - FIBRINOLYSIS W01030206 - COAGULATION INHIBITORS/THROMBOPHILIA MARKERS W01030207 - HAEMOSTASIS CALIBRATORS/CONTROLS
IVDR Classe C
IVR 605 W01030201 - GENERAL COAGULATION TESTS W01030203 - SPECIAL COAGULATION TESTS W01030206 - COAGULATION INHIBITORS/THROMBOPHILIA MARKERS W01030207 - HAEMOSTASIS CALIBRATORS/CONTROLS
IVDR Classe C

Certificat HX 1512506-1

Aperçu

Validité

Organisme notifié

Dispositifs couverts

Caractéristiques

Historique

Changements de statut

Remplace

Périmètre de couverture

Documents

Certificat HX 1512506-1

Aperçu

Validité

Fabricant

Organisme notifié

Dispositifs couverts

Caractéristiques

Historique

Changements de statut

Remplace

Périmètre de couverture

Documents

Fabricant