Siemens Healthcare Diagnostics Inc.

Certificat HX 1290554-1

Rév. Rev. 22Réémis

Valide jusqu'au: 3 mars 2027

Le certificat HX 1290554-1 est un certificat Système de management de la qualité valide délivré à Siemens Healthcare Diagnostics Inc. et enregistré dans EUDAMED. Valable jusqu'au 3 mars 2027. Consultez la fiche complète du certificat sur MD Atlas.

Aperçu

Numéro de certificat: HX 1290554-1
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 1290554-1Rev. 22

Validité

Délivré le: 12 juin 2026
Valide à partir du: 12 juin 2026
Valide jusqu'au: 3 mars 2027

Fabricant

Fabricant
SRN du fabricant: US-MF-000016560
Pays du fabricant: États-Unis

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

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

Historique

Remplace

HX 1290554-1Système de management de la qualitéComplété29 mars 2026 → 15 sept. 2026

Périmètre de couverture

IVDR Classe B17IVDR Classe C13IVDR Classe D3

33 périmètres

IVR 0605: Devices intended to be used for monitoring of levels of medicinal products, substances or biological components W01020801 - CARDIOVASCULAR TDM W01020802 - CENTRAL NERVOUS SYSTEMS TDM W01020803 - ANTIBIOTIC TDM / ANTIVIRUS TDM W01020804 - ANTI-ASTHMA TDM W01020806 - IMMUNOSUPPRESSANT TDM W01020902 - TOXICOLOGY W01021522 - STANDARDS AND CALIBRATORS IMMUNOCHEMISTRY W01029003 - BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
IVDR Classe C
IVR 0607: Devices intended to be used for detection of pregnancy or fertility testing W01020501 - FERTILITY FUNCTION HORMONES / PROTEINS W01020502 - PREGNANCY TESTING HORMONES / PROTEINS W01021522 - STANDARDS AND CALIBRATORS IMMUNOCHEMISTRY
IVDR Classe C
IVR 0608: Devices intended to be used for screening, determination or monitoring of physiological markers W01020190 - OTHER SPECIFIC PROTEINS W01021522 - STANDARDS AND CALIBRATORS IMMUNOCHEMISTRY
IVDR Classe C
INFECTIOUS DISEASES IVR 0501: Devices intended to be used for pre-natal screening of women in order to determine their immune status towards transmissible agents W01050401 - RUBELLA VIRUS W01050402 - CYTOMEGALOVIRUS W01050403 - HERPES SIMPLEX VIRUS W01050501 - TOXOPLASMA W01050808 - CONTROLS - INFECT. IMMUNOLOGY
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 W01050202 - HEPATITIS B VIRUS W01050808 - CONTROLS - INFECT. IMMUNOLOGY
IVDR Classe D
IVR 0502: Devices intended to be used to detect the presence of, or exposure to transmissible agents in blood, blood components, cells, tissues or organs, or in any of their derivatives, to assess their suitability for transfusion, transplantation or cell administration including sexually transmitted agents
IVDR Classe D
CLINICAL CHEMISTRY IVR 0608: Devices intended to be used for screening, determination or monitoring of physiological markers W01010207 - CREATININE W01010213 - GLUCOSE W01010503 - CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) W01010701 - ELECTROLYTE ELECTRODES
IVDR Classe C
IVR 0608: Devices intended to be used for screening, determination or monitoring of physiological markers W01020101 - IMMUNOGLOBULINS (EXCEPT IGE), W01020102 - COMPLEMENT COMPONENTS, W01020103 - TRANSPORT PROTEINS W01020104 - LIPOPROTEINS, W01020190 - OTHER SPECIFIC PROTEINS, W01020601 - DIABETES ASSAYS (HORMONES) W01020690 - VARIOUS INDIVIDUAL AND SPECIFIC HORMONES
IVDR Classe B
IVR 0608: Devices intended to be used for screening, determination or monitoring of physiological markers W02010102 - LIMITED PANEL CHEMISTRY ANALYSERS
IVDR Classe B
IVR 0602: Devices intended to be used for screening, determination or monitoring of physiological markers for a specific disease W01010103 - ALANINE AMINO-TRANSFERASE W01010110 - ASPARTATE AMINO-TRANSFERASE W01010111 - CHOLINESTERASE W01010210 - FRUCTOSAMINE W01010216 - IRON (CC) W01010217 - IRON BINDING CAPACITY - TOTAL (CC) W01010503 - CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) W01010215 - HIGH DENSITY LIPOPROTEIN CHOLESTEROL W01010221 - LOW DENSITY LIPOPROTEIN CHOLESTEROL INCLUDING SD-LDL
IVDR Classe B
IVR 0608: Devices intended to be used for screening, determination or monitoring of physiological markers W01010105 - ALKALINE PHOSPHATASE - TOTAL W01010119 - LACTATE DEHYDROGENASE L ( LDH - L --> P ) W01010123 - LIPASE W01010201 - ALBUMIN (CC) W01010203 - BILIRUBIN W01010204 - UREA/BLOOD UREA NITROGEN W01010218 - LACTATE W01010230 - TOTAL PROTEIN W01010232 - URIC ACID W01010301 - AMMONIA W01010302 - BICARBONATE
IVDR Classe B
HAEMATOLOGY / HAEMOSTASIS / IMMUNOHAEMATOLOGY / HISTOLOGY / CYTOLOGY IVR 0608: Devices intended to be used for screening, determination or monitoring of physiological markers W01030101 - REAGENTS FOR (AUTOMATED) HAEMATOLOGY ANALYZER W01030105 - HAEMATOLOGY CONTROLS AND CALIBRATORS HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS IVR 0608: Devices intended to be used for screening, determination or monitoring of physiological markers W02020101 - AUTOMATED 5 PART DIFFERENTIAL HEMATOLOGY ANALYSERS
IVDR Classe B
IMMUNOCHEMISTRY (IMMUNOLOGY) IVR 0602: Devices intended to be used for screening, determination or monitoring of physiological markers for a specific disease W01020103 - TRANSPORT PROTEINS W01020190 - OTHER SPECIFIC PROTEINS W01020401 - FREE TRIIODOTHYRONINE W01020402 - FREE THYROXINE W01020405 - TRIIODOTHYRONINE W01020406 - T- UPTAKE W01020407 - THYROXINE W01020410 - THYROID STIMULATING HORMONE W01020601 - DIABETES ASSAYS (HORMONES)
IVDR Classe B
IVR 0605: Devices intended to be used for monitoring of levels of medicinal products, substances or biological components W01020901 - DRUGS OF ABUSE W01020902 - TOXICOLOGY
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 W01050201 - HEPATITIS A VIRUS W01050808 - CONTROLS - INFECT. IMMUNOLOGY
IVDR Classe B
Products of class B for near-patient testing: CLINICAL CHEMISTRY IVR 0608: Devices intended to be used for screening, determination or monitoring of physiological markers W01010602 - URINE TESTING (CC) - RT & POC
IVDR Classe B
IMMUNOCHEMISTRY (IMMUNOLOGY) IVR 0607: Devices intended to be used for detection of pregnancy or fertility testing W01021603 - FERTILITY / PREGNANCY RT & POC
IVDR Classe B
IVR 0607: Devices intended to be used for detection of pregnancy or fertility testing W01020502 - PREGNANCY TESTING HORMONES / PROTEINS W01021520 - CONTROLS - IMMUNOCHEMISTRY
IVDR Classe B
IMMUNOCHEMISTRY (IMMUNOLOGY) IVR 0506: Other devices intended to be used to determine markers of infections/immune status W01021104 - ANTI-STREPTOLYSIN O (QUANTITATIVE)
IVDR Classe B
IMMUNOCHEMISTRY (IMMUNOLOGY) IVR 0301: Devices intended to be used in screening, diagnosis, staging or monitoring of cancer W01020301 - CANCER ANTIGENS W01020303 - ONCOPROTEINS W01020390 - OTHER TUMOUR MARKERS W01021520 - CONTROLS - IMMUNOCHEMISTRY W01021522 - STANDARDS AND CALIBRATORS IMMUNOCHEMISTRY W01029003 - BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC) W01020603 - BONE AND MINERAL METABOLISM ASSAYS
IVDR Classe C

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