Domestic manufacturer · Haryana · India

SCEPTRE 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
448
Manufacturing
448
Import
0
FDA clearances
0

Risk-class mix (CDSCO)

Class A (low risk)Lowest-risk devices29
Class BLow–moderate risk413
Class CModerate–high risk6
Class D (high risk)Highest-risk devices0

CDSCO device licences

LAPAROSCOPE, GENERAL & PLASTIC SURGERY · Class BMFG · 2026-03-26

THESE ELECTRODES ARE INTENDED FOR USE IN MINIMALLY INVASIVE SURGICAL PROCEDURES WHERE MONOPOLAR ELECTROSURGICAL CUTTING AND COAGULATION ARE DESIRED., (DERMATOLOGICAL & PLASTIC SURGERY OR CAUTERY PENCIL-(S#35)

MFG/MD/2019/000204 · Haryana
Haemodialysis Catheter · Class BMFG · 2026-03-26

i-A CATHETER USE FOR EXCHANGING BLOOD TO AND FROM THE HAEMODIALYSIS MACHINE FORM THE PATIENT. (Sr.No. 55) ii-THE SINGLE-NEEDLE DIALYSIS, IN WHICH CASE ONLY ONE CANNULA OR A SINGLE LUMEN CATHETER IS USED TO ACCESS THE BLOOD. -(Sr. No. …

MFG/MD/2019/000204 · Haryana
Hydrogen Peroxide 6%w/v Solution · Class BMFG · 2026-02-03

For Cleaning of Medical Devices.

MFG/MD/2020/000219 · Haryana
Pre-saturated wipe with Isopropyl Alcohol I.P. 90% v/v solution. · Class BMFG · 2026-01-06

For Cleaning of Medical Devices.

MFG/MD/2020/000219 · Haryana
Pre- Saturated wipes with Hydrogen Peroxide 6%w/v Solution · Class BMFG · 2026-01-06

For Cleaning of Medical Devices.

MFG/MD/2020/000219 · Haryana
BALLOON DIALATION VESSEL CATHETER · Class BMFG · 2025-12-29

INTENDED FOR USE IN PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY OF THE RENAL, TIBIAL, POPLITEAL, FEMORAL AND PERONEAL ARTERIES. THESE CATHETERS ARE NOT FOR USE IN CORONARY ARTERIES. (SR. NO. 40)

MFG/MD/2019/000204 · Haryana
RADITIONAL SINGLE USE SYRINGE WITHOUT SAFETY FEATURE (STERILE HYPODERMIC SYRINGE FOR SINGLE USE) · Class BMFG · 2025-11-28

INTEND TO INJECT FLUIDS INTO OR WITHDRAW FLUIDS FROM THE BODY. (SR. NO.191)

MFG/MD/2019/000204 · Haryana
BIOPSY NEEDLE KIT · Class BMFG · 2025-11-28

A set of Neurosurgical instruments designed to allow multiple biopsies from one or more targets in one trajectory (S. No. 168)

MFG/MD/2019/000204 · Haryana
GUIDING CATHETER · Class BMFG · 2025-11-28

The Guide Catheter Provides support for device advancement. (S. No. 54)

MFG/MD/2019/000204 · Haryana
Haemodialysis Catheter · Class BMFG · 2025-11-28

i-CATHETER USE FOR EXCHANGING BLOOD TO AND FROM THE HAEMODIALYSIS MACHINE FORM THE PATIENT (Sr.No. 55)

MFG/MD/2019/000204 · Haryana
MEASURED VOLUME IV SET · Class BMFG · 2025-11-28

IT IS INTENDED FOR USE IN THE ADMINISTRATIOIN OF FLUIDS FROM A CONTAINER INTO THE PATIENT'S VASCULAR SYSTEM THROUGH A VASCULAR ACESSES DEVICES (S.No. 196)

MFG/MD/2019/000204 · Haryana
FISTULA NEEDLE · Class BMFG · 2025-11-28

TO CONNECT BLOOD LINES WITH THE BLOOD VESSELS THROUGH NEEDLE WHEN THE DIALYSIS IS CARRIED OUT. (S.No. 178)

MFG/MD/2019/000204 · Haryana
TRACHEAL (ENDOTRACHEAL) TUBE · Class BMFG · 2025-11-28

INSERTS THE TUBE WITH THE HELP OF A LARYNGOSCOPE, AN INSTRUNENT THAT PERMITS TO SEE THE UPPER PORTION OF THE TRACHEA, JUST BELOW THE VOCAL CORDS. (S.No. 144)

MFG/MD/2019/000204 · Haryana
Hemodialysis Cannula · Class BMFG · 2025-11-28

ALLOWING THE ARTERIAL BLOOD TO FLOW TO THE DIALYZER AND THE DIALYZED BLOOD TO RETURN FROM THE DIALYZER TO THE CIRCULATION THROUGH THE CANNULA IN THE VEIN. (S.NO 250)

MFG/MD/2019/000204 · Haryana
ARTERIAL CATHETER · Class BMFG · 2025-11-28

INTENDED TO BE USED IN CONJUNCTION WITH STEERABLE GUIDEWIRES IN ORDER TO ACCESS DISCREATE REGIONS OF THE CORONARY AND PERIPHERIAL ARTERIAL VASCULATATURE (SR. NO. 38)

MFG/MD/2019/000204 · Haryana
SURGICAL STAPLES · Class BMFG · 2025-11-28

SURGICALS STAPLES ARE SPECILIZED STAPLES USED IN SURGERY IN PLACE OF SUTURES TO CLOSED SKIN WOUNDS, CONNECT OR REMOVE PARTS OF BODY DURING SURGERY (S.No. 329)

MFG/MD/2019/000204 · Haryana
COTTON GRUDGES AND BANDAGES · Class AMFG · 2025-11-28

ADHESIVE BANDAGES, GAUGE BANDAGES PRESSURE BANDAGES, TRACTION BANDAGES, MEDICAL ABSORBENT (FIBER) BANDAGES. (S.No 332)

MFG/MD/2019/000204 · Haryana
Multiple Lumen Catheter · Class BMFG · 2025-11-28

INTENDED FOR MONITORING CENTRAL VENOUS PRESSURE (CVP), SAMPLINGBLOOD AND ADMINISTMTION OF MULTIPLE IV SOLUTION OR DRUGS (S. NO. 61)

MFG/MD/2019/000204 · Haryana
ASPIRATION AND INJECTION NEEDLE · Class BMFG · 2025-11-28

A THIN NEEDLE IS INSERTED INTO AN AREA OF ABDOMINALAPPEARING TISSUE OR BODY FLUID. AS WITH OTHER TYPES OF BIOPSIES, THE SAMPLE COLLECTED DURING FINE NEEDLE ASPIRATION CAN HELP MAKE A DIAGNOSIS OR RULE OUT CONDITIONS SUCH AS CANCER. (S.No. 1…

MFG/MD/2019/000204 · Haryana
Peritoneal Dialysis Catheter · Class BMFG · 2025-11-28

THAT ALLOWS DILAYSIS FLUIDS TO ENTER THE A BDOMINAL CAVITY. DWELL INSIDE FOR A WHILE, AND THEN DRAIN BACK OUT AGAIN (SR. NO. 68)

MFG/MD/2019/000204 · Haryana
INTRAMUSCULAR PRESSURE MONITORING CATHETER · Class BMFG · 2025-11-28

A modified fibre optic transducer tipped catheter system for measuring intramuscular pressures during exercise was determined (SR. No. 57)

MFG/MD/2019/000204 · Haryana
Single Needle Hemodialysis Catheter/Blood Lines · Class BMFG · 2025-11-28

THE SINGLE-NEEDLE DIALYSIS, IN WHICH CASE ONLY ONE CANNULA OR SINGLE LUMEN CATHETER IS USED TO ACCESS THE BLOOD (SR. NO. 74)

MFG/MD/2019/000204 · Haryana
Haemodialysis Catheter · Class BMFG · 2025-11-28

CATHETER USE FOR EXCHANGING BLOOD TO AND FROM THE HAEMODIALYSIS MACHINE FORM THE PATIENT (Sr.No. 55)

MFG/MD/2019/000204 · Haryana
TRANSFUSION OR PERFUSION SETS FOR SINGLE USE · Class BMFG · 2025-11-28

TRANSFUSION SET IS USED TO ADMINISTER BLOOD/DRUGS TO A PATIENT'S VASCULAR SYSTEM THROUGH A NEEDLE OR CATHETER INSERTED INTO A VEIN. (S.No. 197)

MFG/MD/2019/000204 · Haryana
TRACHEOSTOMY TUBE/TRACHEAL TUBE · Class BMFG · 2025-11-28

A BREATHING TUBE INSERTED INTO A TRACHEOTOMY USED TO OBTAIN A CLOSED CIRCUIT FOR VENTILATION (S. NO 29)

MFG/MD/2019/000204 · Haryana
URINARY DRAINAGE UNIT · Class BMFG · 2025-11-28

A closed urinary drainage system consists of a catheter inserted into the urinary bladder and connected via tubing to a drainage bag (Sr. No. 121)

MFG/MD/2019/000204 · Haryana
BONE MARROW MARROW NEEDLE · Class BMFG · 2025-11-28

NEEDLE INSERTED IN BONE MARROW TO COLLECT SAMPLE (S.No. 172)

MFG/MD/2019/000204 · Haryana
EPIDURAL NEEDLE · Class BMFG · 2025-11-28

INTENDED FOR TRANSIENT DELIVERY OF ANASTHETIC TO PROVIDE REGIONAL ANESTHESIA OR TO FACILITATE PLACEMENT OF AN EPIDURAL CATHETER. (S.No. 179)

MFG/MD/2019/000204 · Haryana
BALLOON DIALATION VESSEL CATHETER · Class BMFG · 2025-11-28

INTENDED FOR USE IN PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY OF THE RENAL, TIBIAL, POPLITEAL, FEMORAL AND PERONEAL ARTERIES. THESE CATHETERS ARE NOT FOR USE IN CORONARY ARTERIES. (SR. NO. 40)

MFG/MD/2019/000204 · Haryana
Hemodialysis Cannula · Class BMFG · 2025-11-28

ALLOWING THE ARTERIAL BLOOD TO FLOW TO THE DIALYZER AND THE DIALYZED BLOOD TO RETURN FROM THE DIALYZER TO THE CIRCULATION THROUGH THE CANNULA IN THE VEIN (S. No. 250)

MFG/MD/2019/000204 · Haryana
3 WAY STOP COCK AS AN ACCESSORY TO PERFUSION SETS · Class BMFG · 2025-11-28

IT IS INDICATED FOR FLUID FLOW DIRECTIONAL CONTROL AND FOR PROVIDING ACCESS PORT FOR ADMINISTRATION OF SOLUTION, WITHDRAWAL OF FLUID AND PRESSURE MONITORING (S. No. 200)

MFG/MD/2019/000204 · Haryana
Single Needle Hemodialysis Catheter/Blood Lines · Class BMFG · 2025-11-28

THE SINGLE-NEEDLE DIALYSIS, IN WHICH CASE ONLY ONE CANNULA OR SINGLE LUMEN CATHETER IS USED TO ACCESS THE BLOOD (SR. NO. 74)

MFG/MD/2019/000204 · Haryana
RADIOGRAPHIC (NON VASCULAR) CATHETER · Class BMFG · 2025-11-28

INTERVENTIONAL RADIOLOGIST OBTAIN IMAGES USING NEEDLES AND NARROW TUBES CALLED CATHETERS, RATHER THAN BY MAKING LARGE INCISION INTO THE BODY AS IN TRADITIONAL SURGERY. (SR. NO. 69)

MFG/MD/2019/000204 · Haryana
SUCTION TIP AND CATHETER · Class BMFG · 2025-11-28

SUCTION CATHETERS FEATURE A WHISTLE TIP AND A THUMB CONTROL PORT FOR PRECISE AND ACCURATE SUCTIONING (SR. NO. 36)

MFG/MD/2019/000204 · Haryana
ALCOHOL SWABS · Class AMFG · 2025-11-28

IT IS A SINGLE USE, STERILE DEVICE CONTAINING 70% ISOPROPYL ALCOHOL USED FOR SCRUBBING AND ALLOWING DRYING AND WILL DISINFECT NEEDLESS ACCESS SITES PRIOR TO USE. (S.No. 346)

MFG/MD/2019/000204 · Haryana
EXTENSION SETS · Class BMFG · 2025-11-28

EXTENSION SETS ARE STERILE DEVICES FOR SINGLE USE ONLY. THEY ARE INTENDED TO BE USED AS PART OF A SYSTEM FOR THE INFUSION OF FLUIDS/MEDICATIONS IN MEDICAL APPLICATIONS. (S.No. 203)

MFG/MD/2019/000204 · Haryana
INTRODUCER SHEATH · Class CMFG · 2025-11-07

INTENDED TO PROVIDE EASIER ACCESS TO THE FEMORAL, POPLITEAL AND INFRAPOPLITEAL ARTERIES

MFG/MD/2020/000063
CENTRAL VENOUS CATHETER · Class CMFG · 2025-11-07

It is indicated FOR USE IN PATIENTS REQUIRING ADMINISTRATION OF SOLUTIONS , BLOOD SAMPLING, CENTRAL VENOUS CATHETER, PRESSURE MONITORING AND INJECTION OF CONTRAST MEDIA

MFG/MD/2020/000063
HEMODIALYSIS CATHETER ( LONG TERM) · Class CMFG · 2025-11-07

A DIALYSIS CATHETER IS A CATHETER USED FOR EXCHANGING BLOOD TO AND FROM THE HEMODIALYSIS MACHINE FROM THE PATIENT.THE DIALYSIS CATHETER CONTAINS TWO LUMENS : VENOUS ARTERIAL

MFG/MD/2020/000063
Dressing Packs · Class BMFG · 2025-10-31

Used to absorb extrude of wound and Blood after Surgical Procedure.

MFG/MD/2020/000219 · Haryana
Dressing Packs · Class BMFG · 2025-10-31

Used to absorb extrude of wound and Blood after Surgical Procedure.

MFG/MD/2020/000219 · Haryana
Garment, Protective for Incontinence · Class AMFG · 2025-10-31

Intended to protect an incontinent patient?s garment from patient?s excreta.

MFG/MD/2020/000219 · Haryana
Dressing Packs · Class BMFG · 2025-10-31

Used to absorb extrude of wound and Blood after Surgical Procedure.

MFG/MD/2020/000219 · Haryana
Dressing Packs · Class BMFG · 2025-10-31

Used to absorb extrude of wound and Blood after Surgical Procedure.

MFG/MD/2020/000219 · Haryana
Pre-saturated wipe with Isopropyl Alcohol B.P. 70% v/v solution. · Class BMFG · 2025-10-09

For Cleaning of Medical Devices.

MFG/MD/2020/000219 · Haryana
Garment, Protective for Incontinence · Class AMFG · 2025-09-10

Intended to protect an incontinent patient?s garment from patient?s excreta.

MFG/MD/2020/000219 · Haryana
CATHETER /DOUBLE & TRIPLE LUMEN · Class BMFG · 2025-09-02

CATHETER USE FOR EXCHANGING BLOOD TO AND FROM THE HAEMODIALYSIS MACHINE FORM THE PATIENT

MFG/MD/2019/000204 · Haryana
CATHERS / SINGLE NEEDLE/ LUMEN CATHETER · Class BMFG · 2025-09-02

THE SINGLE-NEEDLE DIALYSIS , IN WHICH CASE ONLY ONE CANNULA OR A SINGLE-LUMEN CATHETER IS USED TO ACCESS THE BLOOD

MFG/MD/2019/000204 · Haryana
CATHERS / SINGLE NEEDLE/ LUMEN CATHETER · Class BMFG · 2025-09-02

THE SINGLE-NEEDLE DIALYSIS , IN WHICH CASE ONLY ONE CANNULA OR A SINGLE-LUMEN CATHETER IS USED TO ACCESS THE BLOOD

MFG/MD/2019/000204 · Haryana
CATHERS / SINGLE NEEDLE/ LUMEN CATHETER · Class BMFG · 2025-09-02

THE SINGLE-NEEDLE DIALYSIS , IN WHICH CASE ONLY ONE CANNULA OR A SINGLE-LUMEN CATHETER IS USED TO ACCESS THE BLOOD

MFG/MD/2019/000204 · Haryana

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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