Domestic manufacturer · Delhi · India

ASPEN LABORATORIES PVT. LTD.

CDSCO licensing intelligence, reconciled with the manufacturer’s global footprint · AI-reviewed · expert verification in progress — not yet independently verified.

CDSCO licences

564

Manufacturing

527

Import

37

FDA clearances

55

Risk-class mix (CDSCO)

Class A (low risk)	Lowest-risk devices	34
Class B	Low–moderate risk	450
Class C	Moderate–high risk	58
Class D (high risk)	Highest-risk devices	22

CDSCO device licences

SAFETY LANCET · Class BIMPORT · 2026-03-09

Capillary Blood Sampling

IMP/MD/2026/000164 · from China

Sterile Lancet for Single Use · Class BIMPORT · 2026-03-09

Capillary Blood Sampling

IMP/MD/2026/000164 · from China

ASO/CRP/RF CONTROL, High Level · Class CIMPORT · 2025-12-24

Used to evaluate the precision and accuracy of ASO/CRP/RF determination in human serum by turbidity method

IMP/IVD/2025/000187 · from Spain

HDL&LDL CAL · Class BIMPORT · 2025-12-24

Used to calibrate HDL/LDL parameters

IMP/IVD/2025/000187 · from Spain

ASO TURBI CALIBRATOR · Class BIMPORT · 2025-12-24

Used to calibrate ASO determination by turbidity method

IMP/IVD/2025/000187 · from Spain

ASO/CRP/RF CONTROL, Low Level · Class CIMPORT · 2025-12-24

Used to evaluate the precision and accuracy of ASO/CRP/RF determination in human serum by turbidity method

IMP/IVD/2025/000187 · from Spain

ASO TURBI · Class BIMPORT · 2025-12-24

Used for measurement of ASO in human serum/plasma

IMP/IVD/2025/000187 · from Spain

RF TURBI · Class BIMPORT · 2025-12-24

Used for measurement of RF in human serum/plasma

IMP/IVD/2025/000187 · from Spain

CRP TURBI CAL · Class CIMPORT · 2025-12-24

Used to calibrate CRP determination by turbidity method

IMP/IVD/2025/000187 · from Spain

RF TURBI CAL · Class CIMPORT · 2025-12-24

Used to calibrate RF determination by turbidity method

IMP/IVD/2025/000187 · from Spain

CRP TURBI · Class CIMPORT · 2025-12-24

Used for measurement of C-reactive Protein (CRP) in human serum/plasma

IMP/IVD/2025/000187 · from Spain

Hematology Calibrator Kit · Class BMFG · 2025-12-09

Hematology calibrator kit is designed for use in the calibration of hematology analyzers.

MFG/IVD/2020/000015 · North West Delhi Division

Blood Glucose Meter Kit · Class CMFG · 2025-11-13

To measure the concentration of glucose in blood.

MFG/IVD/2019/000071

Malaria Pf/Pv (Bivalent) Antigen Rapid Test · Class CMFG · 2025-11-13

Test kit for detection of Malaria Pf/Pv antigen(s)

MFG/IVD/2020/000116

Slide Maker & Stainer · Class AMFG · 2025-10-30

Slide Maker & Stainer is an automated slide preparation instrument which accomplishes automatic slide making and staining with clinical samples.

MFG/IVD/2020/000015 · North West Delhi Division

Erythrocyte Sedimentation Rate (ESR) Analyzer · Class AMFG · 2025-10-30

Aspen SED-110 and Aspen SED-220 ESR Analyzers reports sedimentation rate in mm/hr. It is a nonspecific, quantitative result. Testing is done using EDTA/whole blood samples obtained by venipuncture or capillary blood collection.

MFG/IVD/2020/000015 · North West Delhi Division

Syphilis Rapid Test · Class DMFG · 2025-09-17

Test kit for detection of Syphilis

MFG/IVD/2019/000071

HBsAg Rapid Test · Class DMFG · 2025-09-17

Test kit for detection of Hepatitis B Surface Antigen

MFG/IVD/2019/000071

Kala Azar Antigen Rapid Card Test · Class CMFG · 2025-09-17

Test kit for Detection of Kaal Azar

MFG/IVD/2019/000071

Malaria Pf/Pv (Bivalent) Antigen Rapid Test · Class CMFG · 2025-09-17

Test kit for detection of Malaria Pf/Pv antigen(s)

MFG/IVD/2019/000071

HIV Rapid Card Test · Class DMFG · 2025-09-17

Test kit for detection of HIV

MFG/IVD/2019/000071

Dengue NS1+IgG/IgM Combo Rapid Card Test · Class CMFG · 2025-09-17

Test kit for detection of Dengue NS1+IgG/IgM

MFG/IVD/2019/000071

Drugs of Abuse Rapid Test ((1 parameter to multiparameter) · Class CMFG · 2025-09-17

Test kit for detection of various combinations of Drug of Abuse parameters and drug metabolites in urine e.g. Amphetamine, Barbiturates, Benzodiazepines, Cocaine, Ecstasy (MDMA), Morphine, Marijuana, Opiate , Tricyclic Antidepressants, Phen…

MFG/IVD/2019/000071

Troponin-I Rapid Card Test · Class CMFG · 2025-09-17

Test kit for detection of Troponin-I

MFG/IVD/2019/000071

Anti-D Blood Grouping Reagent · Class DMFG · 2025-09-17

Test kit for Blood Grouping

MFG/IVD/2019/000071

Dengue NS1 Antigen Rapid Card Test · Class CMFG · 2025-09-17

Test kit for detection of Dengue NS1 Antigen

MFG/IVD/2019/000071

Chikungunya Antigen Rapid Card Test · Class CMFG · 2025-09-17

Test kit for detection of Chikungunya Antigen

MFG/IVD/2019/000071

HCV Rapid Card Test Kit · Class DMFG · 2025-09-17

Test kit for detection of Hepatitis C Virus

MFG/IVD/2019/000071

Malaria Pf/Pan Antigen Rapid Test · Class CMFG · 2025-09-17

Test kit for Detection of Malaria Pf/Pan Antigen

MFG/IVD/2019/000071

Thromboplastin (Prothrombin Time) Reagent Kit · Class CMFG · 2025-09-17

Test kit for estimation of Prothrombin Time

MFG/IVD/2019/000071

Malaria Pan Antigen Rapid Test · Class CMFG · 2025-09-17

Test kit for Detection of Malaria Pan Antigen

MFG/IVD/2019/000071

Filaria Antigen Rapid Card Test · Class CMFG · 2025-09-17

Test kit for detection of Filaria Antigen

MFG/IVD/2019/000071

Toxoplasma Rapid Card Test Kit · Class CMFG · 2025-09-17

Test kit for Detection of Toxoplasma

MFG/IVD/2019/000071

Dengue NS1 ELISA · Class CMFG · 2025-09-17

Test kit for detection of Dengue NS1 Antigen

MFG/IVD/2019/000071

HCV ELISA Test Kit · Class DMFG · 2025-09-17

Test kit for detection of Hepatitis C Virus

MFG/IVD/2019/000071

PSA Rapid Card Test Kit · Class CMFG · 2025-09-17

Test kit for Detection of Prostate-Specific Antigen (PSA)

MFG/IVD/2019/000071

hCG (Total & Beta) Elisa Kit · Class CMFG · 2025-09-17

Test kit for Detection of Total and Beta hCG

MFG/IVD/2019/000071

Malaria Pf Antigen Rapid Test · Class CMFG · 2025-09-17

Test kit for detection of Malaria Pf. Antigen

MFG/IVD/2019/000071

CEA ELISA Kit · Class CMFG · 2025-09-17

Test kit for Detection of Carcinoembryonic antigen (CEA)

MFG/IVD/2019/000071

HBsAg ELISA Test Kit · Class DMFG · 2025-09-17

Test kit for detection of Hepatitis B Surface Antigen

MFG/IVD/2019/000071

Anti-A Blood Grouping Reagent · Class DMFG · 2025-09-17

Test Kit for Blood Grouping

MFG/IVD/2019/000071

Anti-B Blood Grouping Reagent · Class DMFG · 2025-09-17

Test Kit for Blood Grouping

MFG/IVD/2019/000071

HIV ELISA Test Kit · Class DMFG · 2025-09-17

Test kit for detection of HIV

MFG/IVD/2019/000071

H. Pylori Antigen Rapid Card Test · Class CMFG · 2025-09-17

Test kit for Detection of H. Pylori

MFG/IVD/2019/000071

Anti-A/B/D Blood Grouping Combo Reagent Kit · Class DMFG · 2025-09-17

Combo Reagent Kit for Blood Grouping

MFG/IVD/2019/000071

APTT (Activated Partial Thromboplastin) Reagent Kit · Class CMFG · 2025-09-17

Test kit for estimation of APTT

MFG/IVD/2019/000071

ToRCH Range Rapid Card Test · Class CMFG · 2025-09-17

Test kit for Detection of ToRCH parameters

MFG/IVD/2019/000071

INTERLEUKIN-6 (IL-6) CLIA · Class BMFG · 2025-05-21

IL-6 CLIA is a Chemiluminescent Immunoassay (CLIA) for the quantitative determination of Interleukin-6 (IL-6) in human serum or plasma.

MFG/IVD/2020/000015 · North West Delhi Division

FREE ESTRIOL CLIA · Class BMFG · 2025-05-21

Free Estriol CLIA is a Chemiluminescent Immunoassay (CLIA) for the quantitative determination of Free Estriol (FE) in human serum.

MFG/IVD/2020/000015 · North West Delhi Division

INHIBIN-A CLIA · Class BMFG · 2025-05-21

Inhibin A CLIA is a Chemiluminescent Immunoassay (CLIA) for the quantitative determination of inhibin A in human serum.

MFG/IVD/2020/000015 · North West Delhi Division

Global footprint

Cross-rail

The same manufacturer across regulators — 55 FDA clearances, 0 flagged adverse-event signals.

SYSTEM 7500 ABC ELECTROSURGICAL UNIT · GEIFDA · 1998-04-21

SHEATH, ELECTROSURGICAL PENCIL · GEIFDA · 1996-09-13

SYSTEM 6500 ABC ELECTROSURGICAL UNIT · GEIFDA · 1996-07-11

4000 ETM · GEIFDA · 1996-02-20

BEAMER PLUS · GEIFDA · 1995-10-30

EXCALIBUR PLUS ELECTROSURGICAL UNIT · GEIFDA · 1995-08-21

SMOKIEVAC ELECTROSURGICAL PENCIL · GEIFDA · 1995-04-03

ELECTROSURGICAL FLEXIBLE ELECTRODE IN-LINE SUCTION COAGULATOR · GEIFDA · 1994-12-21

EXCALIBUR ELECTROSURGICAL UNIT · GEIFDA · 1993-04-16

SINGLE USE LEE ELECTRODE · HGIFDA · 1992-02-13

BISTAT ELECTROSURGICAL UNIT 60-5400-001 · GEXFDA · 1990-02-13

MF-450 ELECTROSURGICAL UNIT 60-5500-001 · GEIFDA · 1990-02-02

ASPEN ESMARK BANDAGE · FQMFDA · 1987-07-31

RGB CAMERA SYSTEM · FWFFDA · 1987-07-21

TMJ CANNULA SET · DZIFDA · 1987-06-08

A.T.S. 1500 TOURNIQUET · KCYFDA · 1987-03-18

UNIVERSAL CANNULA SYSTEM · HRXFDA · 1986-10-23

A.C.L. GUIDE KIT · FZXFDA · 1986-08-18

ZIMMER VIDEO PRODUCTS AUTOMATIC LIGHT SOURCE · EQHFDA · 1986-02-28

SINGLE AND DUAL TOURNIQUET CUFF · KCYFDA · 1986-02-25

MAGNETIC RETRIEVERFDA · 1985-12-02

MENISCAL STITCHING KITFDA · 1985-10-08

ATS 500 TOURNIQUET · KCYFDA · 1985-10-07

SINGLE USE ARTHROSCOPY ELECTRODE · GEIFDA · 1985-09-03

MASON EQUIPMENT ORGANIZER & ASPEN · FSEFDA · 1984-10-25

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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