Siemens Healthcare Diagnostics Inc.

Certificate HX 1290554-1

Rev. Rev. 22Reissued

Valid until: Mar 3, 2027

Certificate HX 1290554-1 is a valid Quality management system issued to Siemens Healthcare Diagnostics Inc. and registered in EUDAMED. Valid until March 3, 2027. View the full certificate record on MD Atlas.

Overview

Certificate number: HX 1290554-1
Certificate type: Quality management system
Certificate status: Reissued
Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Version: 1
Certificate ID: 0197HX 1290554-1Rev. 22

Validity

Issued: Jun 12, 2026
Valid from: Jun 12, 2026
Valid until: Mar 3, 2027

Notified body

Notified body: TÜV Rheinland LGA Products GmbH
Notified body SRN: 0197
Notified body country: Germany

Covered devices

No specific devices are listed for this certificate.

Characteristics

Sterile: No
Human tissues: No
Animal tissues: No
In vitro diagnostics: —
Initial registration: No
New device: No
Discard allowed: No
SSCP enabled: Yes
Mechanism of scrutiny: No
Intended medical purpose: —
SPP applicable: —
Conditions applicable: No
MOS outside EUDAMED: —
QMS/MOS type: Others

History

Supersedes

HX 1290554-1Quality management systemSupplementedMar 29, 2026 → Sep 15, 2026

Scope coverage

IVDR Class B17IVDR Class C13IVDR Class D3

33 scopes

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 Class 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 Class 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 Class 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 Class 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 Class 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 Class 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 Class 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 Class B
IVR 0608: Devices intended to be used for screening, determination or monitoring of physiological markers W02010102 - LIMITED PANEL CHEMISTRY ANALYSERS
IVDR Class 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 Class 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 Class 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 Class 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 Class 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 Class 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 Class 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 Class B
IMMUNOCHEMISTRY (IMMUNOLOGY) IVR 0607: Devices intended to be used for detection of pregnancy or fertility testing W01021603 - FERTILITY / PREGNANCY RT & POC
IVDR Class B
IVR 0607: Devices intended to be used for detection of pregnancy or fertility testing W01020502 - PREGNANCY TESTING HORMONES / PROTEINS W01021520 - CONTROLS - IMMUNOCHEMISTRY
IVDR Class B
IMMUNOCHEMISTRY (IMMUNOLOGY) IVR 0506: Other devices intended to be used to determine markers of infections/immune status W01021104 - ANTI-STREPTOLYSIN O (QUANTITATIVE)
IVDR Class 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 Class C

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Documents

LanguagesEN

Scope coverage

IVDR Class B17IVDR Class C13IVDR Class D3

33 scopes

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 Class 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 Class 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 Class 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 Class 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 Class 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 Class 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 Class 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 Class B
IVR 0608: Devices intended to be used for screening, determination or monitoring of physiological markers W02010102 - LIMITED PANEL CHEMISTRY ANALYSERS
IVDR Class 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 Class 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 Class 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 Class 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 Class 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 Class 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 Class 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 Class B
IMMUNOCHEMISTRY (IMMUNOLOGY) IVR 0607: Devices intended to be used for detection of pregnancy or fertility testing W01021603 - FERTILITY / PREGNANCY RT & POC
IVDR Class B
IVR 0607: Devices intended to be used for detection of pregnancy or fertility testing W01020502 - PREGNANCY TESTING HORMONES / PROTEINS W01021520 - CONTROLS - IMMUNOCHEMISTRY
IVDR Class B
IMMUNOCHEMISTRY (IMMUNOLOGY) IVR 0506: Other devices intended to be used to determine markers of infections/immune status W01021104 - ANTI-STREPTOLYSIN O (QUANTITATIVE)
IVDR Class 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 Class C

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Certificate HX 1290554-1

Overview

Validity

Notified body

Covered devices

Characteristics

History

Supersedes

Scope coverage

Documents

Certificate HX 1290554-1

Overview

Validity

Manufacturer

Notified body

Covered devices

Characteristics

History

Supersedes

Scope coverage

Documents

Manufacturer