Importer / authorised agent · Delhi · India

ASPEN DIAGNOSTICS PVT. LTD.

CDSCO licensing intelligence, reconciled with the manufacturer’s global footprint · AI-reviewed · expert verification in progress — not yet independently verified.
CDSCO licences
533
Manufacturing
0
Import
533
FDA clearances
0

Risk-class mix (CDSCO)

Class A (low risk)Lowest-risk devices59
Class BLow–moderate risk436
Class CModerate–high risk38
Class D (high risk)Highest-risk devices0

CDSCO device licences

Creatinine Reagent Kit (Enzyme Method) · Class BIMPORT · 2026-03-11

This reagent is applied to the invitro quantitive measurement of creatinine concentration of human serum, plasma or urine.

IMP/IVD/2026/000032 · from China
DIRUI 2 ITEMS (KET,GLU) · Class BIMPORT · 2026-03-11

2 ITEMS (GLU, KET) Reagent Strips for Urinalysis is used for qualitative and semi-quantitative test of ketone (acetoacetic acid) and glucose in urine.

IMP/IVD/2026/000032 · from China
Clinical Chemical Quality Control serum · Class BIMPORT · 2026-03-11

Clinical Chemical Quality Control serum includes Level 1 and Level 2, used for the quality control of clinical analysis determination of many biochemical items.

IMP/IVD/2026/000032 · from China
CREATINE KINASE REAGENT KIT (IFCC METHOD) · Class BIMPORT · 2026-03-11

This reagent is applied to the invitro quantitative measurement of creatine kinase (CK) activity of human serum or plasma. CK is the dipolymerase comprised by two monomer subunits of M (muscle) mode and B (brain) mode. M mode combines with …

IMP/IVD/2026/000032 · from China
CYSTATIN C REAGENT KIT (LATEX ENHANCED IMMUNOTURBIDIMETRIC ASSAY) · Class BIMPORT · 2026-03-11

The reagent is used for the in vitro quantitative measurement of cystatin C content in human serum or plasma. Cystatin C is a secreted protein, widely present in various body fluids, such as cerebrospinal fluid, blood, saliva, semen. Study …

IMP/IVD/2026/000032 · from China
DIRUI 1 ITEM (GLU) · Class BIMPORT · 2026-03-11

1 ITEM (GLU) Reagent Strips for Urinalysis is used for qualitative and semi-quantitative test of glucose in urine.

IMP/IVD/2026/000032 · from China
CHOLINSTERASE REAGENT KIT (BUTYRYLTHIOCHOLINE SUBSTRATE METHOD) · Class BIMPORT · 2026-03-11

This reagent is applied to the invitro quantitative measurement of activity of cholinsterase in human serum or plasma. Serum cholinesterase comes from the liver. Under the circumstance of acute and chronic hepatitis, hypoalbuminemia, its ac…

IMP/IVD/2026/000032 · from China
Cleaning Liquid for Refractometer and Turbidimeter · Class BIMPORT · 2026-03-11

To clean the refractometer and turbidimeter of H Series Urine Analyzer, FUS Series Urinalysis Hybrid and MUS Series Urinalysis System.

IMP/IVD/2026/000032 · from China
COMPLEMENT4 REAGENT KIT (IMMUNOTURBIDIMETRIC ASSAY) · Class BIMPORT · 2026-03-11

This reagent is applied to in vitro quantitative determination of complement 4 content in human serum. Complement C4 is an important component of complement classical pathway. Its determination helps the diagnosis, treatment and etiology of…

IMP/IVD/2026/000032 · from China
CREATINE KINASE MB ISOENZYME REAGENT KIT (IMMUNOINHIBITION) · Class BIMPORT · 2026-03-11

This reagent is applied to the invitro quantitative measurement of activity of CK-MB isoenzyme in human serum . CK is the dipolymerase comprised by two monomer subunits of M (muscle) mode and B (brain) mode. M mode combines with B mode mono…

IMP/IVD/2026/000032 · from China
Clinical Chemical Calibration Serum · Class BIMPORT · 2026-03-11

Clinical Chemical Calibration Serum includes Level 1 and Level 2, used for the calibration of clinical analysis determination of many biochemical items.

IMP/IVD/2026/000032 · from China
CS- Anti- Bacterial Phosphor- Free Detergent · Class BIMPORT · 2026-03-11

For cleaning reagent probe, reaction cuvette and soaking reaction cup of the CS series Auto-Chemistry Analyzer.

IMP/IVD/2026/000032 · from China
Direct Bilirubin Kit (Vanadate Oxidation Method) · Class BIMPORT · 2026-03-11

This reagent is applied to the invitro quantitive measurement of the concentration of D-bilirubin (DB) of human serum.

IMP/IVD/2026/000032 · from China
Direct Bilirubin Reagent Kit (Diazo Salt Method) · Class BIMPORT · 2026-03-11

This reagent is applied to the invitro quantitative measurement of D-bilirubin concentration of human serum or plasma.

IMP/IVD/2026/000032 · from China
BILE ACID REAGENT KIT (ENZYMATIC CYCLING METHOD) · Class BIMPORT · 2026-03-11

This reagent is applied to the invitro quantitative measurement of total bile acid concent in human serum. Human total bile acid library in the day is relatively balanced. Daily bile acid is mainly excreted through feces, balance takes chol…

IMP/IVD/2026/000032 · from China
Auto-Chemistry Analyzer (CS-T240) · Class AIMPORT · 2026-03-11

The product is a fully automated instrument for quantitative analysis of chemical components in human samples (including serum, plasma, urine, cerebrospinal fluid, hydrothorax and ascites), which can assist in the diagnosis of normal people…

IMP/IVD/2026/000032 · from China
CHOLESTEROL REAGENT KIT (ENZYME METHOD) · Class BIMPORT · 2026-03-11

This reagent is applied to the invitro quantitive determination of total cholesterol concentration in human serum. Serum cholesterol determination can be used as indicator to diagnose liver function, biliary function, intestinal absorption,…

IMP/IVD/2026/000032 · from China
CHLORIDE REAGENT KIT (THIOCYANATE METHOD) · Class BIMPORT · 2026-03-11

This reagent is applied to the invitro quantitative measurement of chloride concentration of human serum, plasma. Chloride is the major extracellular anion. The blood chloride level changes with sodium concentration changes in the circums…

IMP/IVD/2026/000032 · from China
CS-ISE Detergent · Class BIMPORT · 2026-03-11

Used to clean ISE electrode of CS series Auto-Chemistry Analyzer.

IMP/IVD/2026/000032 · from China
Cleaning Liquid (Concentrated type) · Class BIMPORT · 2026-03-11

It is used for cleaning and rinsing of tubing system. It will effectively clean the remained urine and other test-interfering particles to avoid cross-contamination among urine sample.

IMP/IVD/2026/000032 · from China
COMPLEMENT 3 REAGENT KIT (IMMUNOTURBIDIMETRIC ASSAY) · Class BIMPORT · 2026-03-11

This reagent is applied to in vitro quantitative determination of complement 3 content in human serum. The complement system is composed of at least 20 kinds of plasma protein and several kinds of receptor proteins, through the enzymatic ca…

IMP/IVD/2026/000032 · from China
Copper Reagent Kit (PAESA Chromogenic Agent Assay) · Class BIMPORT · 2026-03-11

It is used for the in vitro quantitative detection of the content of the copper in human serum.

IMP/IVD/2026/000032 · from China
Auto-Chemistry Analyzer (CS-T240 Plus) · Class AIMPORT · 2026-03-11

The product is a fully automated instrument for quantitative analysis of chemical components in human samples (including serum, plasma, urine, cerebrospinal fluid, hydrothorax and ascites), which can assist in the diagnosis of normal people…

IMP/IVD/2026/000032 · from China
CALCIUM REAGENT KIT (CRESOLPHTHALEIN COMPLEXONE METHOD) · Class BIMPORT · 2026-03-11

This reagent is applied to the invitro quantitative determination of calcium concentration of serum, plasma or urine. Calcium has many functions in the human body. In addition to be the material element of bone and teeth, it also has the fu…

IMP/IVD/2026/000032 · from China
Auto-Chemistry Analyzer (CS-T180) · Class AIMPORT · 2026-03-11

The product is a fully automated instrument for quantitative analysis of chemical components in human samples (including serum, plasma, urine, cerebrospinal fluid, hydrothorax and ascites), which can assist in the diagnosis of normal people…

IMP/IVD/2026/000032 · from China
CS-Alkaline Detergent · Class BIMPORT · 2026-03-11

For cleaning sample probe and reaction cuvette of CS series Auto-Chemistry Analyzer.

IMP/IVD/2026/000032 · from China
Auto-Chemistry Analyzer (CS-680) · Class AIMPORT · 2026-03-11

The product is a fully automated instrument for quantitative analysis of chemical components in human samples (including serum, plasma, urine, cerebrospinal fluid, hydrothorax and ascites), which can assist in the diagnosis of normal people…

IMP/IVD/2026/000032 · from China
CARBON DIOXIDE REAGENT KIT(ENZYMATIC METHOD) · Class BIMPORT · 2026-03-11

This reagent is applied to the invitro quantitative determination of carbon dioxide content in human serum or plasma. The test of carbon dioxide content is mainly used for auxiliary diagnosis of diabetic acidosis, severe diarrhea, shock, ki…

IMP/IVD/2026/000032 · from China
CALCIUM REAGENT KIT (ARSENAZO III METHOD) · Class BIMPORT · 2026-03-11

This reagent is applied to the invitro quantitative determination of calcium concentration of serum, plasma or urine. Calcium has many functions in the human body. In addition to be the material element of bone and teeth, it also has the fu…

IMP/IVD/2026/000032 · from China
Alpha - HYDROXYBUTYRIC DEHYDROGENASE REAGENT KIT (DGKC METHOD) · Class BIMPORT · 2026-03-11

This reagent is applied to the in vitro quantitive determination of the activity of Alpha-hydroxybutyrate dehydrogenase (Alpha ?HBDH) in serum or plasma. This method is selective method for type I isoenzyme of lactate dehydrogenase, which i…

IMP/IVD/2026/000032 · from China
5?- NUCLEOTIDASE REAGENT KIT (ENZYME METHOD) · Class BIMPORT · 2026-03-11

The reagent is used for the in vitro quantitative measurement of 5?- nucleotidase activity in human serum or plasma. 5?-nucleotidase is a enzyme that catalyze nucleotide -5?- monophosphate, and hydrolyze into nucleotide and inorganic phosph…

IMP/IVD/2026/000032 · from China
Adenosine Deaminase Reagent Kit (Enzyme Method) · Class BIMPORT · 2026-03-11

This reagent is used for the in vitro quantitative measurement of adenosine deaminase activity in human serum or plasma.

IMP/IVD/2026/000032 · from China
Alpha-L-Fucosidase Reagent Kit (CNPF Substrate Method) · Class BIMPORT · 2026-03-11

It is used for in vitro quantitative detection of the activity of Alpha-L-fucosidase in human serum or plasma.

IMP/IVD/2026/000032 · from China
ALANINE AMINOTRANSFERASE LIQUID KIT (IFCC METHOD) · Class BIMPORT · 2026-03-11

This reagent is applied to the invitro quantitive measurement of the activity of ALT in human serum. ALT Activity Increase Hepatobiliary disease: infectious hepatitis, toxic hepatitis, fatty liver and cholangitis, etc. Cardiovascular diseas…

IMP/IVD/2026/000032 · from China
ALBUMIN REAGENT KIT (BROMCRESOL GREEN METHOD) · Class BIMPORT · 2026-03-11

This reagent is for the invitro quantitative determination of albumin concentrotion in human serum or plasma. Albumin is the major plasma protein. Its main functions include adjusting the distribution of extracellular liquid; transporting i…

IMP/IVD/2026/000032 · from China
ALKALINE PHOSPHATASE REAGENT KIT (IFCC METHOD) · Class BIMPORT · 2026-03-11

This reagent is applied to the invitro quantitive measurement of the activity of alkaline phosphatase in human serum or plasma Alkaline phosphatase is a group of non- specific phosphatase. They catalyze the same type of biochemical reaction…

IMP/IVD/2026/000032 · from China
Alpha-1 - MICROGLOBULIN REAGENT KIT (LATEX ENHANCED IMMUNOTURBIDIMETRIC ASSAY) · Class BIMPORT · 2026-03-11

The reagent kit is used for the in vitro quantitative detection of the content of Alpha 1-MG in human serum samples. Serum ?1-MG can sensitively reflect the changes in glomerular filtration function. Under normal circumstances, about 99.9% …

IMP/IVD/2026/000032 · from China
AMYLASE REAGENT KIT (IFCC METHOD) · Class BIMPORT · 2026-03-11

This reagent is applied to the in-vitro quantitative determination of a-amylase activity of human serum or urine a-amylase is mainly from salivary gland and exocrine gland, and catalyze the hudrolysis of amylum and other related a-1, 4 gly…

IMP/IVD/2026/000032 · from China
Anti-Streptolysin O Kit (LATEX ENHANCED IMMUNOTURBIDIMETRIC ASSAY) · Class BIMPORT · 2026-03-11

This reagent is applied to the in vitro quantitative determination of anti- streptolysin O in human serum. Streptolysin O is one of the metabolites of A hemolytic streptococci. It is a protein with hemolytic activity and antigenicity. A hem…

IMP/IVD/2026/000032 · from China
Apolipoprotein A1 Reagent Kit (Immunoturbidimetric Method) · Class BIMPORT · 2026-03-11

This reagent is applied to the invitro quantitative measurement of apolipoprotein A1 (APO A1) content of human serum.

IMP/IVD/2026/000032 · from China
Apolipoprotein B Reagent kit (Immunoturbidimetric Method) · Class BIMPORT · 2026-03-11

This reagent is applied to the invitro quantitative measurement of apolipoprotein B (Apo B) content of human serum .

IMP/IVD/2026/000032 · from China
Aspartate Aminotransferase Reagent Kit (IFCC Method) · Class BIMPORT · 2026-03-11

This reagent is applied to the invitro quantitative measurement of aminotransferase (AST) activity in human serum or plasma.

IMP/IVD/2026/000032 · from China
Auto-Chemistry Analyzer (CS-1200) · Class AIMPORT · 2026-03-11

The product is a fully automated instrument for quantitative analysis of chemical components in human samples (including serum, plasma, urine, cerebrospinal fluid, hydrothorax and ascites), which can assist in the diagnosis of normal people…

IMP/IVD/2026/000032 · from China
Auto-Chemistry Analyzer (CS-1300B) · Class AIMPORT · 2026-03-11

The product is a fully automated instrument for quantitative analysis of chemical components in human samples (including serum, plasma, urine, cerebrospinal fluid, hydrothorax and ascites), which can assist in the diagnosis of normal people…

IMP/IVD/2026/000032 · from China
Auto-Chemistry Analyzer (CS-1600) · Class AIMPORT · 2026-03-11

The product is a fully automated instrument for quantitative analysis of chemical components in human samples (including serum, plasma, urine, cerebrospinal fluid, hydrothorax and ascites), which can assist in the diagnosis of normal people…

IMP/IVD/2026/000032 · from China
Auto-Chemistry Analyzer (CS-2000) · Class AIMPORT · 2026-03-11

The product is a fully automated instrument for quantitative analysis of chemical components in human samples (including serum, plasma, urine, cerebrospinal fluid, hydrothorax and ascites), which can assist in the diagnosis of normal people…

IMP/IVD/2026/000032 · from China
Auto-Chemistry Analyzer (CS-300B) · Class AIMPORT · 2026-03-11

The product is a fully automated instrument for quantitative analysis of chemical components in human samples (including serum, plasma, urine, cerebrospinal fluid, hydrothorax and ascites), which can assist in the diagnosis of normal people…

IMP/IVD/2026/000032 · from China
Cleaning liquid II · Class BIMPORT · 2026-03-11

For the cleaning and rinsing of the tubing system.

IMP/IVD/2026/000032 · from China
Auto-Chemistry Analyzer (CS-480) · Class AIMPORT · 2026-03-11

The product is a fully automated instrument for quantitative analysis of chemical components in human samples (including serum, plasma, urine, cerebrospinal fluid, hydrothorax and ascites), which can assist in the diagnosis of normal people…

IMP/IVD/2026/000032 · from China
DIRUI 2 ITEMS (PRO,GLU) · Class BIMPORT · 2026-03-11

DIRUI 2 ITEMS (PRO, GLU) Reagent Strips for Urinalysis is used for qualitative and semiquantitative test of protein and glucose in urine.

IMP/IVD/2026/000032 · 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.

Early access

MedevIQ is in private preview.

We're onboarding hospitals, manufacturers, regulators and research teams in waves. Tell us how you'd use MedevIQ and we'll get back within a working week.

We'll reply within a working week.

Access by invitation while v1 finalizes.