Importer / authorised agent · Maharashtra · India

Mindray Medical India Pvt. Ltd.

CDSCO licensing intelligence, reconciled with the manufacturer’s global footprint · AI-reviewed · expert verification in progress — not yet independently verified.
CDSCO licences
1,007
Manufacturing
0
Import
1,007
FDA clearances
0

Risk-class mix (CDSCO)

Class A (low risk)Lowest-risk devices62
Class BLow–moderate risk754
Class CModerate–high risk164
Class D (high risk)Highest-risk devices27

CDSCO device licences

Antistreptolysin "O" Calibrator · Class BIMPORT · 2026-04-27

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 China
ASO/CRP/RF Triple Control · Class CIMPORT · 2026-04-27

ASO/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 China
Bilirubin Direct Kit (VOX Method) · Class BIMPORT · 2026-04-27

In 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 China
ADA Calibrator · Class BIMPORT · 2026-04-27

ADA Calibrator is used for calibration of quantitative determination of Adenosine Deaminase (ADA) analyte on Mindray BS series chemistry analyzers.

IMP/IVD/2026/000067 · from China
ACE Control · Class BIMPORT · 2026-04-27

ACE 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 China
Apolipoprotein A1 Kit (Turbidimetry Method) · Class BIMPORT · 2026-04-27

In 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 China
Apolipoprotein B Kit (Turbidimetry Method) · Class BIMPORT · 2026-04-27

In 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 China
Adenosine Deaminase Kit (Enzymatic Colorimetric Method) · Class BIMPORT · 2026-04-27

In 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 China
ADA Control · Class BIMPORT · 2026-04-27

ADA 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 China
Alkaline Phosphatase Kit (IFCC Modified Method) · Class BIMPORT · 2026-04-27

In 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 China
Antistreptolysin "O" Kit (Latex Immunoturbidimetric Method) · Class BIMPORT · 2026-04-27

In 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 China
Alanine Aminotransferase Kit (IFCC Method) · Class BIMPORT · 2026-04-27

In 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 China
Angiotensin Converting Enzyme Kit (Enzymatic Colorimetric Assay Method) · Class BIMPORT · 2026-04-27

In 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 China
Aspartate Aminotransferase Kit (IFCC Method) · Class BIMPORT · 2026-04-27

In 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 China
Albumin Kit (Bromcresol Green Method) · Class BIMPORT · 2026-04-27

In 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 China
Non-sterile Intramedullary Nailing Systems · Class CIMPORT · 2026-04-07

The product is intended for internal fixation of tibia

IMP/MD/2026/000259 · from China
Non-sterile Bone Screws · Class CIMPORT · 2026-04-07

The 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 China
Non-sterile Intramedullary Nailing Systems · Class CIMPORT · 2026-04-07

The product is intended for internal fixation of femur.

IMP/MD/2026/000259 · from China
Chemistry Analyzer · Class AIMPORT · 2026-04-07

The 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 China
Chemiluminescence Immunoassay Analyzer · Class AIMPORT · 2026-04-07

The 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 China
Non-sterile Bone Plates · Class CIMPORT · 2026-04-07

The 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 China
M-5LEO(I) LYSE · Class BIMPORT · 2026-04-02

M-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 China
M-30CFL LYSE · Class BIMPORT · 2026-04-02

For 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 China
M-6DR DILUENT · Class BIMPORT · 2026-04-02

The M-6DR DILUENT participates in the measurement of RET-related parameters together with M-6FR DYE / M-68FR DYE.

IMP/IVD/2025/000118 · from China
Hemoglobin A1c Control · Class BIMPORT · 2026-04-02

Quality control over the test on HbA1c in whole blood to monitor and assess the accuracy of the test result.

IMP/IVD/2025/000118 · from China
LC LYSE · Class BIMPORT · 2026-04-02

The LC LYSE is used for dissolving RBCs before sample analysis.

IMP/IVD/2025/000118 · from China
M-6FD DYE · Class BIMPORT · 2026-04-02

The M-6FD DYE participates in WBC differentiation in the DIFF channel together with M-6LD LYSE.

IMP/IVD/2025/000118 · from China
M-20CFL LYSE · Class BIMPORT · 2026-04-02

For 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 China
M-10CFL LYSE · Class BIMPORT · 2026-04-02

For 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 China
M-6LN LYSE · Class BIMPORT · 2026-04-02

This 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 China
C-Reaction Protein Control · Class CIMPORT · 2026-04-02

C-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 China
M-5LEO(II) LYSE · Class BIMPORT · 2026-04-02

M-5LEO(II) Lyse cooperates with M-5LEO(I) Lyse to 4-differentiate WBCs.

IMP/IVD/2025/000118 · from China
M-6LD LYSE · Class BIMPORT · 2026-04-02

The M-6LD LYSE participates in WBC differentiation in the DIFF channel together with M-6FD DYE / M-68FD DYE

IMP/IVD/2025/000118 · from China
M-6LH LYSE · Class BIMPORT · 2026-04-02

The M-6LH LYSE formulated to measure the hemoglobin-related parameters.

IMP/IVD/2025/000118 · from China
C-Reactive Protein (CRP) Calibrator · Class CIMPORT · 2026-04-02

The 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 China
DS DILUENT · Class BIMPORT · 2026-04-02

The DS DILUENT participates in the measurement of parameters related to RBC, PLT, WBC, RET and NRBC.

IMP/IVD/2025/000118 · from China
C-reactive Protein (CRP) Kit (Latex Immunoturbidimetric Method) · Class CIMPORT · 2026-04-02

The CRP reagent is used for in vitro quantitative measurement of CRP concentration in human whole blood.

IMP/IVD/2025/000118 · from China
M-6FN DYE · Class BIMPORT · 2026-04-02

The M-6FN DYE participates in the measurement of Baso-related and NRBC-related parameters together with M-6LN LYSE.

IMP/IVD/2025/000118 · from China
Hemoglobin A1c Calibrator · Class BIMPORT · 2026-04-02

The product is used to calibrate HbA1c in whole blood to guarantee that the test result is accurate.

IMP/IVD/2025/000118 · from China
ESR Solution Reagent · Class BIMPORT · 2026-04-02

The ESR Solution Reagent is used to clean the ESR measurement channels.

IMP/IVD/2025/000118 · from China
M-6FR DYE · Class BIMPORT · 2026-04-02

The M-6FR DYE participates in the measurement of RET-related parameters together with M-6DR DILUENT

IMP/IVD/2025/000118 · from China
Total Thyroxine(CLIA) · Class BIMPORT · 2026-03-18

The 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 China
Total Triiodothyronine(CLIA) · Class BIMPORT · 2026-03-18

The 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 China
Thyroid Function Multi Control · Class BIMPORT · 2026-03-18

Mindray 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 China
Testosterone (CLIA) · Class BIMPORT · 2026-03-18

The 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 China
25-OH-Vitamin D Total (CLIA) · Class BIMPORT · 2026-03-18

The 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 China
Free Triiodothyronine(CLIA) · Class BIMPORT · 2026-03-18

The 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 China
Immunoassay Multi Control · Class BIMPORT · 2026-03-18

Mindray 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 China
System Detection Solution · Class BIMPORT · 2026-03-18

For use with the CL-series analyzer in system maintenance.

IMP/IVD/2025/000132 · from China
Anti-Tg Calibrators · Class BIMPORT · 2026-03-18

Mindray 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 China

Global footprint

Cross-rail

The 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.

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