Mindray Medical India Pvt. Ltd.
Risk-class mix (CDSCO)
| Class A (low risk) | Lowest-risk devices | 62 |
| Class B | Low–moderate risk | 754 |
| Class C | Moderate–high risk | 164 |
| Class D (high risk) | Highest-risk devices | 27 |
CDSCO device licences
Antistreptolysin "O" Calibrator is used for calibration of quantitative determination of Antistreptolysin "O" (ASO) analyte on Mindray BS series chemistry analyzers
IMP/IVD/2026/000067 · from ChinaASO/CRP/RF Triple Control is used for quality control of quantitative determination of rheumatism analytes by monitoring accuracy and precision of Mindray BS series chemistry analyzers and test ability of clinical laboratory.
IMP/IVD/2026/000067 · from ChinaIn vitro test for the quantitative determination of direct bilirubin concentration in human serum and plasma on Mindray BS series chemistry analyzers. It is intended to be used for aiding to diagnose and monitoring hepatobiliary diseases, d…
IMP/IVD/2026/000067 · from ChinaADA Calibrator is used for calibration of quantitative determination of Adenosine Deaminase (ADA) analyte on Mindray BS series chemistry analyzers.
IMP/IVD/2026/000067 · from ChinaACE Control is used for quality control of quantitative determination of Angiotensin Converting Enzyme (analyte by monitoring accuracy and precision of Mindray BS series chemistry analyzers and test ability of clinical laboratory.
IMP/IVD/2026/000067 · from ChinaIn vitro test for the quantitative determination of Apolipoprotein A1 (ApoA1) concentration in human serum on Mindray BS series chemistry analyzers. It is intended to be used for risk prediction of cardiovascular disease.
IMP/IVD/2026/000067 · from ChinaIn vitro test for the quantitative determination of Apolipoprotein B (ApoB) concentration in human serum on Mindray BS series chemistry analyzers. It is intended to be used for risk prediction of cardiovascular disease
IMP/IVD/2026/000067 · from ChinaIn vitro test for the quantitative determination of Adenosine Deaminase (ADA) activity in human serum on Mindray BS series chemistry analyzers. It is intended to be used for aiding to diagnose hepatobiliary diseases.
IMP/IVD/2026/000067 · from ChinaADA Control is used for quality control of quantitative determination of Adenosine Deaminase ( analyte by monitoring accuracy and precision of Mindray BS series chemistry analyzers and test ability of clinical laboratory.
IMP/IVD/2026/000067 · from ChinaIn vitro test for the quantitative determination of Alkaline phosphatase (ALP) activity in human serum and plasma on Mindray BS series chemistry analyzers It is intended to be used for aiding to diagnose hepatobiliary diseases.
IMP/IVD/2026/000067 · from ChinaIn vitro test for the quantitative determination of Antistreptolysin ?O? (ASO) concentration in human serum and plasma on Mindray BS series chemistry analyzers. It is intended to be used for aiding to diagnose and monitoring the therapeutic…
IMP/IVD/2026/000067 · from ChinaIn vitro test for the quantitative determination of Alanine Aminotransferase (ALT) activity in human serum and plasma on Mindray BS series chemistry analyzers. It is intended to be used for aiding to diagnose and monitoring hepatobiliary di…
IMP/IVD/2026/000067 · from ChinaIn vitro test for the quantitative determination of Angiotensin Converting Enzyme (ACE) activity in human serum on Mindray BS series chemistry analyzers. It is intended to be used for aiding to diagnose pulmonary diseases.
IMP/IVD/2026/000067 · from ChinaIn vitro test for the quantitative determination of Aspartate Aminotransferase (AST) activity in human serum and plasma on Mindray BS series chemistry analyzers. It is intended to be used for aiding to diagnose and monitoring hepatobiliary …
IMP/IVD/2026/000067 · from ChinaIn vitro test for the quantitative determination of Albumin (ALB) concentration in human serum and plasma on Mindray BS series chemistry analyzers It is int ended to be used for diagnosis and monitoring hypoalbuminemia.
IMP/IVD/2026/000067 · from ChinaThe product is intended for internal fixation of tibia
IMP/MD/2026/000259 · from ChinaThe product is intended for the temporary internal fixation of bone segments or fragments, include pelvis and limbs and maxillofacial bones during the surgery.
IMP/MD/2026/000259 · from ChinaThe product is intended for internal fixation of femur.
IMP/MD/2026/000259 · from ChinaThe instrument is an automated chemistry analyzer for in vitro diagnostic use in clinical laboratories and designed for in vitro quantitative determination of clinical chemistries in serum, plasma, urine and cerebrospinal fluid samples.
IMP/IVD/2020/001055 · from ChinaThe instrument is an automated analyzer for immunological analysis. It is designed for determination of analytes in serum, plasma and other human body fluids.
IMP/IVD/2020/001055 · from ChinaThe product is intended for the temporary internal fixation of bone segments or fragments, include pelvis and limbs and maxillofacial bones during the surgery.
IMP/MD/2026/000259 · from ChinaM-5LEO(I) Lyse breaks down red blood cell membrane and cooperates with M-5LEO(II) Lyse to 4-differentiate WBCs.
IMP/IVD/2025/000118 · from ChinaFor use as a cyanide-free lytic reagent for quantitatively determining hemoglobin and for counting and sizing leukocytes. Use as directed in instrument operator's manual.
IMP/IVD/2025/000118 · from ChinaThe M-6DR DILUENT participates in the measurement of RET-related parameters together with M-6FR DYE / M-68FR DYE.
IMP/IVD/2025/000118 · from ChinaQuality control over the test on HbA1c in whole blood to monitor and assess the accuracy of the test result.
IMP/IVD/2025/000118 · from ChinaThe LC LYSE is used for dissolving RBCs before sample analysis.
IMP/IVD/2025/000118 · from ChinaThe M-6FD DYE participates in WBC differentiation in the DIFF channel together with M-6LD LYSE.
IMP/IVD/2025/000118 · from ChinaFor use as a cyanide-free lytic reagent for quantitatively determining hemoglobin and for counting and sizing leukocytes. Use as directed in instrument operator's manual.
IMP/IVD/2025/000118 · from ChinaFor use as a cyanide-free lytic reagent for quantitatively determining hemoglobin and for counting and sizing leukocytes. Use as directed in instrument operator's manual.
IMP/IVD/2025/000118 · from ChinaThis product participates in the measurement of Baso-related and NRBC-related parameters together with M-6FN DYE / M-68FN DYE.
IMP/IVD/2025/000118 · from ChinaC-Reactive Protein Control is used for internal quality control of the CRP concentration measurement in human whole blood by Mindray's measurement system calibrated with Mindray calibrator.
IMP/IVD/2025/000118 · from ChinaM-5LEO(II) Lyse cooperates with M-5LEO(I) Lyse to 4-differentiate WBCs.
IMP/IVD/2025/000118 · from ChinaThe M-6LD LYSE participates in WBC differentiation in the DIFF channel together with M-6FD DYE / M-68FD DYE
IMP/IVD/2025/000118 · from ChinaThe M-6LH LYSE formulated to measure the hemoglobin-related parameters.
IMP/IVD/2025/000118 · from ChinaThe calibrator is intended to be used with the auto hematology analyzers and specific protein analyzers manufactured by Shenzhen Mindray Bio-Medical Electronics Co., Ltd, and their reagents for calibration of C-Reactive protein measurement …
IMP/IVD/2025/000118 · from ChinaThe DS DILUENT participates in the measurement of parameters related to RBC, PLT, WBC, RET and NRBC.
IMP/IVD/2025/000118 · from ChinaThe CRP reagent is used for in vitro quantitative measurement of CRP concentration in human whole blood.
IMP/IVD/2025/000118 · from ChinaThe M-6FN DYE participates in the measurement of Baso-related and NRBC-related parameters together with M-6LN LYSE.
IMP/IVD/2025/000118 · from ChinaThe product is used to calibrate HbA1c in whole blood to guarantee that the test result is accurate.
IMP/IVD/2025/000118 · from ChinaThe ESR Solution Reagent is used to clean the ESR measurement channels.
IMP/IVD/2025/000118 · from ChinaThe M-6FR DYE participates in the measurement of RET-related parameters together with M-6DR DILUENT
IMP/IVD/2025/000118 · from ChinaThe CL-series T4 assay is a Chemiluminescent Immunoassay (CLIA) for the quantitative determination of total thyroxine (T4) levels in human serum or plasma. Measurement obtained by this device is used as an aid in the diagnosis and treatmen…
IMP/IVD/2025/000132 · from ChinaThe CL-series T3 assay is a Chemiluminescent Immunoassay (CLIA) for the quantitative determination of total triiodothyronine (T3) in human serum or plasma. Measurements obtained by this device are used as an aid in the diagnosis and treatme…
IMP/IVD/2025/000132 · from ChinaMindray Thyroid Function Multi Control is used for quality control by monitoring the accuracy and precision of Mindray CL-series Chemiluminescence Immunoassay Analyzer and test ability of clinical laboratory in the quantitative measurement …
IMP/IVD/2025/000132 · from ChinaThe CL-series TESTO assay is an automated Chemiluminescent Immunoassay (CLIA) for the quantitative determination of total testosterone (TESTO) in human serum and plasma. Measurements of testosterone are used for auxiliary diagnosis of disea…
IMP/IVD/2025/000132 · from ChinaThe CL-series VD-T assay is an automated Chemiluminescent Immunoassay (CLIA) for the quantitative determination of total 25-OH-Vitamin D in human serum or plasma. It is used an aid in assessment of vitamin D sufficiency.
IMP/IVD/2025/000132 · from ChinaThe CL-series FT3 assay is a Chemiluminescent Immunoassay (CLIA) for the quantitative determination of free triiodothyronine (FT3) in human serum or plasma. Measurements obtained by this device are used as an aid in the diagnosis and treatm…
IMP/IVD/2025/000132 · from ChinaMindray Immunoassay Multi Control is used for quality control by monitoring the accuracy and precision of Mindray CL-series Chemiluminescence Immunoassay Analyzer and test ability of clinical laboratory in the quantitative measurement of Im…
IMP/IVD/2025/000132 · from ChinaFor use with the CL-series analyzer in system maintenance.
IMP/IVD/2025/000132 · from ChinaMindray Anti-Tg Calibrators (Anti-Tg CAL) are intended to calibrate the quantitative antibody to thyroglobulin (Anti-Tg) assay on Mindray CL-series Chemiluminescence Immunoassay Analyzer.
IMP/IVD/2025/000132 · from ChinaGlobal footprint
Cross-railThe same manufacturer across regulators — 0 FDA clearances, 0 flagged adverse-event signals.
No FDA clearances linked — India-domestic footprint.
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.