Siemens Healthcare Diagnostics Products Ltd.

Certificat HX 7091840-1

Rév. Rev. 10Réémis

Valide jusqu'au: 10 mars 2027

Le certificat HX 7091840-1 est un certificat Système de management de la qualité valide délivré à Siemens Healthcare Diagnostics Products Ltd. et enregistré dans EUDAMED. Valable jusqu'au 10 mars 2027. Consultez la fiche complète du certificat sur MD Atlas.

Aperçu

Numéro de certificat: HX 7091840-1
Type de certificat: Système de management de la qualité
Statut du certificat: Réémis
Législation applicable: IVDR [Règlement (UE) 2017/746 relatif aux dispositifs médicaux de diagnostic in vitro]
Version: 1
Identifiant du certificat: 0197HX 7091840-1Rev. 10

Validité

Délivré le: 12 juin 2026
Valide à partir du: 12 juin 2026
Valide jusqu'au: 10 mars 2027

Fabricant

Fabricant: Siemens Healthcare Diagnostics Products Ltd.
SRN du fabricant: GB-MF-000016339
Pays du fabricant: Royaume-Uni

Organisme notifié

Organisme notifié
SRN de l'organisme notifié: 0197
Pays de l'organisme notifié: Allemagne

Dispositifs couverts

Aucun dispositif spécifique n'est listé pour ce certificat.

Caractéristiques

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: Oui
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Historique

Remplace

HX 7091840-1Système de management de la qualitéComplété7 juil. 2025 → 6 janv. 2027

Périmètre de couverture

IVDR Classe C13IVDR Classe B7IVDR Classe D1

21 périmètres

IMMUNOCHEMISTRY (IMMUNOLOGY) IVR 0301: Devices intended to be used in screening, diagnosis, staging or monitoring of cancer W01020390 - OTHER TUMOUR MARKERS
IVDR Classe C
HAEMATOLOGY / HAEMOSTASIS / IMMUNOHAEMATOLOGY / HISTOLOGY / CYTOLOGY IVR 0608: Devices intended to be used for screening, determination or monitoring of physiological markers W01030603 - TUMOUR NECROSIS FACTORS (TNFα, TNFβ, ...)
IVDR Classe B
IMMUNOCHEMISTRY (IMMUNOLOGY) IVR 0602: Devices intended to be used for screening, determination or monitoring of physiological markers for a specific disease W01020601 - DIABETES ASSAYS (HORMONES) W01020702 - VITAMINES W01021112 - ANTI-CYCLIC CITRULLINATED PEPTIDE W01021520 - CONTROLS - IMMUNOCHEMISTRY W01020690 - VARIOUS INDIVIDUAL AND SPECIFIC HORMONES W01020701 - ANEMIA W01020603 - BONE AND MINERAL METABOLISM ASSAYS W01020604 - ENDOCRINE HORMONES AND PEPTIDES
IVDR Classe B
IVR 0603: Devices intended to be used for screening, confirmation/determination, or monitoring of allergies and intolerances W01021520 - CONTROLS - IMMUNOCHEMISTRY W01020202 - IMMUNOGLOBULIN E - SPECIFIC, MONOTEST/MONORESULT W01020203 - IMMUNOGLOBULIN E - MONOTEST/MONORESULT - MULTI AG W01020205 - IMMUNOGLOBULIN E - SCREEN W01020208 - ALLERGENE SPECIFIC IGG W01020201 - IMMUNOGLOBULIN E – TOTAL W01020299 - ALLERGY TESTS – OTHER – Rev.8
IVDR Classe B
IVR 0608: Devices intended to be used for screening, determination or monitoring of physiological markers W01020103 - TRANSPORT PROTEINS W01020601 - DIABETES ASSAYS (HORMONES) W01021520 - CONTROLS - IMMUNOCHEMISTRY W01029003 - BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC) W01020603 - BONE AND MINERAL METABOLISM ASSAYS W01020604 - ENDOCRINE HORMONES AND PEPTIDES W01021307 - HOMOCYSTEINE W01029099 - IMMUNOCHEMISTRY REAGENTS - OTHER W01020409 - THYROID BINDING GLOBULIN W01020406 - T- UPTAKE
IVDR Classe B
INFECTIOUS DISEASES IVR 0503: Devices intended to be used to detect the presence of, or exposure to an infectious agent including sexually transmitted agents W01050808 - CONTROLS - INFECT. IMMUNOLOGY W01050404 - EPSTEIN BARR VIRUS W01050104 - HELICOBACTER PYLORI
IVDR Classe B
CLINICAL CHEMISTRY IVR 0602: Devices intended to be used for screening, determination or monitoring of physiological markers for a specific disease W01010114 - CREATINE KINASE - MB ACTIVITY (CC)
IVDR Classe C
HAEMATOLOGY / HAEMOSTASIS / IMMUNOHAEMATOLOGY / HISTOLOGY / CYTOLOGY IVR 0602: Devices intended to be used for screening, determination or monitoring of physiological markers for a specific disease W01030205 - FIBRINOLYSIS W01030207 - HAEMOSTASIS CALIBRATORS/CONTROLS
IVDR Classe C
IMMUNOCHEMISTRY (IMMUNOLOGY) IVR 0301: Devices intended to be used in screening, diagnosis, staging or monitoring of cancer W01020301 - CANCER ANTIGENS W01021520 - CONTROLS - IMMUNOCHEMISTRY W01021522 - STANDARDS AND CALIBRATORS IMMUNOCHEMISTRY W01020603 - BONE AND MINERAL METABOLISM ASSAYS W01020408 – THYROGLOBULIN
IVDR Classe C
IVR 0401: Devices intended to be used in screening/confirmation of congenital/inherited disorders W01021520 - CONTROLS - IMMUNOCHEMISTRY W01020502 - PREGNANCY TESTING HORMONES / PROTEINS IVR 0506: Other devices intended to be used to determine markers of infections/immune status W01021520 - CONTROLS - IMMUNOCHEMISTRY W01020190 - OTHER SPECIFIC PROTEINS
IVDR Classe C
IVR 0603: Devices intended to be used for screening, confirmation/determination, or monitoring of allergies and intolerances W01021520 - CONTROLS - IMMUNOCHEMISTRY W01020202 - IMMUNOGLOBULIN E - SPECIFIC, MONOTEST/MONORESULT W01020203 - IMMUNOGLOBULIN E - MONOTEST/MONORESULT - MULTI AG
IVDR Classe C
IVR 0605: Devices intended to be used for monitoring of levels of medicinal products, substances or biological components W01020801 - CARDIOVASCULAR TDM W01021520 - CONTROLS - IMMUNOCHEMISTRY W01021522 - STANDARDS AND CALIBRATORS IMMUNOCHEMISTRY W01020804 - ANTI-ASTHMA TDM W01020806 - IMMUNOSUPPRESSANT TDM W01020802 - CENTRAL NERVOUS SYSTEMS TDM
IVDR Classe C
IVR 0607: Devices intended to be used for detection of pregnancy or fertility testing W01021520 - CONTROLS - IMMUNOCHEMISTRY W01020502 - PREGNANCY TESTING HORMONES / PROTEINS W01020501 - FERTILITY FUNCTION HORMONES / PROTEINS
IVDR Classe C
IVR 0501: Devices intended to be used for pre-natal screening of women in order to determine their immune status towards transmissible agents W01050501 - TOXOPLASMA W01050808 - CONTROLS - INFECT. IMMUNOLOGY W01050402 - CYTOMEGALOVIRUS W01050403 - HERPES SIMPLEX VIRUS W01050401 - RUBELLA VIRUS W01050103 - SYPHILIS (TREPONEMA PALLIDUM)
IVDR Classe C
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 W01050202 - HEPATITIS B VIRUS W01050808 - CONTROLS - INFECT. IMMUNOLOGY
IVDR Classe C
IVR 0506: Other devices intended to be used to determine markers of infections/immune status W01030606 - OTHER INTERLEUKINS (EXCEPT FOR IL-6) W01030607 - INTERLEUKINS RECEPTORS (IL-2R,IL6R ...) W01030608 - CYTOKINES CALIBRATORS/CONTROLS W01030609 - INTERLEUKIN 6 (IL-6)
IVDR Classe B
IVR 0602: Devices intended to be used for screening, determination or monitoring of physiological markers for a specific disease W01020502 - PREGNANCY TESTING HORMONES / PROTEINS
IVDR Classe C
IVR 0503 Devices intended to be used to detect the presence of, or exposure to an infectious agent including sexually transmitted agents W01050202 Hepatitis B Virus
IVDR Classe D
IMMUNOCHEMISTRY (IMMUNOLOGY) IVR 0506: Other devices intended to be used to determine markers of infections/immune status W01020502 - PREGNANCY TESTING HORMONES / PROTEINS- Rev.7
IVDR Classe C
IVR 0603: Devices intended to be used for screening, confirmation/determination, or monitoring of allergies and intolerances W01021520 - CONTROLS - IMMUNOCHEMISTRY W01020202 - IMMUNOGLOBULIN E - SPECIFIC, MONOTEST/MONORESULT W01020203 - IMMUNOGLOBULIN E - MONOTEST/MONORESULT - MULTI AG W01020299 - ALLERGY TESTS – OTHER
IVDR Classe C

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