Siemens Healthcare Pvt. Ltd.
Risk-class mix (CDSCO)
| Class A (low risk) | Lowest-risk devices | 116 |
| Class B | Low–moderate risk | 1,964 |
| Class C | Moderate–high risk | 1,346 |
| Class D (high risk) | Highest-risk devices | 45 |
CDSCO device licences
IMMULITE 2000 XPi systems are intended for professional use in a laboratory environment only. Tests performed are intended for in vitro diagnostic use. As with all diagnostic tests, a definitive clinical diagnosis should not be based on the…
IMP/IVD/2026/000075 · from United KingdomThe Automation System is a modular system designed to automate Pre- Analytical and Post-Analytical processing, sample handling in order to automate sample processing in the Laboratory. The system consolidates multiple Analytical instruments…
IMP/IVD/2022/000412 · from SwitzerlandThe Atellica® CH Urine Albumin (UAlb) assay is for in vitro diagnostic use in the quantitative determination of albumin in human urine using the Atellica® CH Analyzer and Atellica® CI Analyzer. Measurement of albumin aids in the diagnosis o…
IMP/IVD/2018/000011 · from United StatesThe Atellica® CH Urine Albumin Calibrator (UAlb CAL) is for in vitro diagnostic use in the calibration of the Atellica® CH Urine Albumin (UAlb) assay on an Atellica® chemistry analyzer.
IMP/IVD/2018/000011 · from United StatesConcentriq AP-Dx is a digital slide viewing and management software system. The system is intended to manage and display digital images of anatomic pathology glass slides for pathologist review, interpretation, and primary diagnosis. Concen…
IMP/IVD/2026/000052 · from United Statessyngo.CT LVO Detection is a dedicated post-processing application intended to be used for the analysis of CT-angiography (CTA) images of the head.
IMP/MD/2021/000437 · from GermanyComputed tomography system intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data.
IMP/MD/2021/000413 · from ChinaThe Atellica? Sample Handler (SH) are intended for identifying samples, moving samples to and from analyzers, storing calibrator and control samples, and tracking onboard samples for the Atellica Solution.
IMP/IVD/2022/000341 · from United StatesAtellica® HEMA 520 OT classifies and enumerates the following parameters in whole blood: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW-CV, RDW-SD, MIC, MAC, PLT, MPV, PCT, PDW, P-LCC, P-LCR, LYM#, LYM%, MON#, MON%, NEU#, NEU%, EOS#, EOS%, BAS#, …
IMP/IVD/2026/000031 · from FranceAtellica® HEMA 530 classifies and enumerates the following parameters in whole blood: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW-CV, RDW-SD, MIC, MAC, PLT, MPV, PCT, PDW, P-LCC, P-LCR, LYM#, LYM%, MON#, MON%, NEU#, NEU%, EOS#, EOS%, BAS#, BAS…
IMP/IVD/2026/000031 · from FranceAtellica® HEMA 520 CT classifies and enumerates the following parameters in whole blood: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW-CV, RDW-SD, MIC, MAC, PLT, MPV, PCT, PDW, P-LCC, P-LCR, LYM#, LYM%, MON#, MON%, NEU#, NEU%, EOS#, EOS%, BAS#, …
IMP/IVD/2026/000031 · from FranceA radiological imaging system that is a combination of a positron emission tomography (PET) camera system for nuclear medicine images, and a computed tomography (CT) camera system for x-ray images. The nuclear medicine images and the x-ray …
IMP/MD/2021/000563 · from United StatesMAMMOVISTA B.smart is a dedicated softcopy review environment for both screening and diagnostic mammography as well as digital breast tomosynthesis. Its user interface and workflow have been optimized to support experienced mammography and …
IMP/MD/2021/000590 · from GermanyThe Atellica® IM DHEAS2 assay is for in vitro diagnostic use in the quantitative determination of DHEAS in human serum and plasma (EDTA and lithium heparin) using the Atellica® IM and Atellica® CI Analyzer. Analyzer. Measurements of DHEAS a…
IMP/IVD/2018/000031 · from United States:A radiological imaging system that is a combination of a positron emission tomography (PET) camera system for nuclear medicine images, and a computed tomography (CT) camera system for x-ray images. The nuclear medicine images and the x-ray…
IMP/MD/2021/000563 · from United StatesA radiological imaging system that is a combination of a positron emission tomography (PET) camera system for nuclear medicine images, and a computed tomography (CT) camera system for x-ray images. The nuclear medicine images and the x-ray …
IMP/MD/2021/000563 · from United StatesThe ADVIA Centaur® NfL Quality Control (NfL QC) is for in vitro diagnostic use in monitoring the precision and accuracy of the ADVIA Centaur® Neurofilament Light Chain (NfL) assay.
IMP/IVD/2018/000031 · from United StatesThe Atellica® IM NfL Quality Control (NfL QC) is for in vitro diagnostic use in monitoring the precision and accuracy of the Atellica® IM Neurofilament Light Chain (NfL) assay.
IMP/IVD/2018/000031 · from United StatesThe ADVIA Centaur® Neurofilament Light Chain (NfL) assay is for in vitro diagnostic use in the quantitative measurement of neurofilament light chain (NfL) in human serum and plasma (EDTA) using the ADVIA Centaur® XP and ADVIA Centaur® XPT s…
IMP/IVD/2018/000031 · from United StatesThe Atellica IM NfL Diluent (NfL DIL) is for the dilution of patient samples above the linear range of the assay.
IMP/IVD/2018/000031 · from United StatesThe Atellica® IM Neurofilament Light Chain (NfL) assay is for in vitro diagnostic use in the quantitative measurement of neurofilament light chain (NfL) in human serum and plasma (EDTA) using the Atellica® IM Analyzer. The Atellica IM NfL a…
IMP/IVD/2018/000031 · from United StatesThe ADVIA Centaur NfL Diluent (NfL DIL) is for the dilution of patient samples above the linear range of the assay.
IMP/IVD/2018/000031 · from United StatesThe Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for patients with malignant or benign diseases. Eclipse TPS is used to plan external beam irradiation with photon, electron and proton beams, as wel…
IMP/MD/2024/000461 · from United StatesThe ARIA Radiation Therapy Management product is a treatment plan and image management application. It enables the authorized user to enter, access, modify, store and archive treatment plan and image data from diagnostic studies, treatment …
IMP/MD/2024/000461 · from United StatesThe MAGNETOM systems are indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross-sectional images, spectroscopic images and/or spectra, and that displays, depending on…
MFG/MD/2021/000225The Atellica® IM NT?proBNPII (PBNPII) assay is for in vitro diagnostic use in the quantitative determination of N?terminal pro?brain natriuretic peptide (NT?proBNP) in human serum and plasma (EDTA and lithium heparin) using the Atellica® IM…
IMP/IVD/2018/000031 · from United StatesThe ADVIA Centaur® NT?proBNPII (PBNPII) assay is for in vitro diagnostic use in the quantitative determination of N?terminal pro?brain natriuretic peptide (NT?proBNP) in human serum and plasma (EDTA and lithium heparin) using the ADVIA Cent…
IMP/IVD/2018/000031 · from United StatesIMDX HPV Genotyping Panel is a Real Time polymerase chain reaction (RTPCR) test intended for the qualitative detection and genotyping of high-risk Human Papillomavirus genotypes from viral nucleic acid extracted from the human cervix canal …
MFG/IVD/2022/000004ARTIS one, as a family of dedicated angiography systems generating fluoroscopic and radiographic X-ray images, is intended for diagnostic imaging, interventional and minimally invasive therapy. Its use is indicated for image guidance in no…
MFG/MD/2021/000225N/T Protein control LC is assayed intralaboratory quality control for assessment of precision and analytical bias in immunonephelometric determination of IgG in urine, and CSF, IgA in CSF, transferrin in urine, albumin in urine and CSF, ?2…
IMP/IVD/2019/000166 · from GermanyIn-vitro diagnostic reagents for the quantitative determination of ?1-microglobulin in human urine using the BN II and BN ProSpec System
IMP/IVD/2019/000166 · from GermanyIn-vitro diagnostic reagents for the quantitative determination of prealbumin (transthyretin) and retinol-binding protein (RbP) in human serum and heparinized plasma by means of immunonephelometry on the BN II and BN ProSpec System.
IMP/IVD/2019/000166 · from GermanyIn vitro diagnostic reagents for quantitative determination of myoglobin in human serum or heparinized and EDTA plasma by means of particle-enhanced immunonephelometry using the BN Systems.
IMP/IVD/2019/000166 · from GermanyIn-vitro diagnostic reagents for the quantitative determination of ceruloplasmin and hemopexin in human serum and heparinized plasma by means of immunonephelometry on the BN II and BN ProSpec System
IMP/IVD/2019/000166 · from GermanyIn-vitro diagnostic reagents for the quantitative determination of IgM in human cerebrospinal fluid (CSF) by means of particle-enhanced immunonephelometry using the BN II and BN ProSpec System.
IMP/IVD/2019/000166 · from GermanyIn vitro diagnostic reagents for the quantitative determination of apolipoprotein A-II (Apo A-II) and apolipoprotein E (Apo E) in human serum with the BN Systems
IMP/IVD/2019/000166 · from GermanyIn-vitro diagnostic for the semi-quantitative determination of anti-streptococcal hyaluronidase in human serum through the inhibition of the enzymatic cleavage of hyaluronic acid
IMP/IVD/2019/000166 · from GermanyN APOE is an in vitro diagnostic reagent for the quantitative determination of apolipoprotein E (Apo E) in human serum as an aid to diagnosis for congenital hyperlipoproteinemia by means of automated Siemens …
IMP/IVD/2019/000166 · from GermanyIn-vitro diagnostic reagent for the quantitative determination of fibronectin in human plasma by means of immunonephelometry on the BN Systems
IMP/IVD/2019/000166 · from GermanyCios Fit is a mobile X-ray system designed to provide X-ray imaging of the anatomical structures of patient during following clinical applications: interventional fluoroscopic, gastro-intestinal, endoscopic, urologic, pain management, ortho…
MFG/MD/2021/000225Cios Fit is a mobile X-ray system designed to provide X-ray imaging of the anatomical structures of patient during following clinical applications: interventional fluoroscopic, gastro-intestinal, endoscopic, urologic, pain management, ortho…
MFG/MD/2021/000225The MAGNETOM systems are indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross-sectional images, spectroscopic images and/or spectra, and that displays, depending on…
MFG/MD/2021/000225The MAASTRO Rectal Applicator Set is intended for use for cancer treatment of the rectum using HDR brachytherapy.
IMP/MD/2024/000541 · from GermanyThe Atellica® IM Thyroglobulin (Tg) assay is for in vitro diagnostic use in the quantitative measurement of thyroglobulin in human serum and plasma (EDTA and lithium heparin) using the Atellica® IM and Atellica® CI Analyzer.
IMP/IVD/2020/001093 · from United KingdomThe ADVIA Centaur aTPOII Diluent is for the dilution of patient samples above the range of the assay.
IMP/IVD/2020/001093 · from United StatesThe Atellica® IM Anti-Thyroid Peroxidase II (aTPOII) assay is for in vitro diagnostic use in the quantitative measurement of autoantibodies against thyroid peroxidase in human serum and plasma (EDTA and lithium heparin) using the Atellica® …
IMP/IVD/2020/001093 · from United KingdomThe Atellica® IM aTPOII Quality Control (aTPOII QC) is for in vitro diagnostic use in monitoring the precision and accuracy of the Atellica® IM Anti-Thyroid Peroxidase II (aTPOII) assay.
IMP/IVD/2020/001093 · from United StatesThe ADVIA Centaur® aTPOII Quality Control (aTPOII QC) is for in vitro diagnostic use in monitoring the precision and accuracy of the ADVIA Centaur® Anti-Thyroid Peroxidase II (aTPOII) assay.
IMP/IVD/2020/001093 · from United StatesThe ADVIA Centaur® Anti-Thyroid Peroxidase II (aTPOII) assay is for in vitro diagnostic use in the quantitative measurement of autoantibodies against thyroid peroxidase in human serum and plasma (EDTA and lithium heparin) using the ADVIA C…
IMP/IVD/2020/001093 · from United KingdomThe Atellica® IM aTPOII Diluent is for the dilution of patient samples above the range of the assay.
IMP/IVD/2020/001093 · from United KingdomGlobal footprint
Cross-railThe same manufacturer across regulators — 30 FDA clearances, 2 flagged adverse-event signals.
Sources: CDSCO (Central Drugs Standard Control Organisation) device licences · openFDA 510(k)/PMA · openFDA MAUDE · MedevIQ manufacturer-canonical. Registry data, AI-reviewed; expert sign-off in progress.