SCEPTRE MEDICAL INDIA PVT LTD
Risk-class mix (CDSCO)
| Class A (low risk) | Lowest-risk devices | 29 |
| Class B | Low–moderate risk | 413 |
| Class C | Moderate–high risk | 6 |
| Class D (high risk) | Highest-risk devices | 0 |
CDSCO device licences
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 · Haryanai-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 · HaryanaFor Cleaning of Medical Devices.
MFG/MD/2020/000219 · HaryanaFor Cleaning of Medical Devices.
MFG/MD/2020/000219 · HaryanaFor Cleaning of Medical Devices.
MFG/MD/2020/000219 · HaryanaINTENDED 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 · HaryanaINTEND TO INJECT FLUIDS INTO OR WITHDRAW FLUIDS FROM THE BODY. (SR. NO.191)
MFG/MD/2019/000204 · HaryanaA set of Neurosurgical instruments designed to allow multiple biopsies from one or more targets in one trajectory (S. No. 168)
MFG/MD/2019/000204 · HaryanaThe Guide Catheter Provides support for device advancement. (S. No. 54)
MFG/MD/2019/000204 · Haryanai-CATHETER USE FOR EXCHANGING BLOOD TO AND FROM THE HAEMODIALYSIS MACHINE FORM THE PATIENT (Sr.No. 55)
MFG/MD/2019/000204 · HaryanaIT 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 · HaryanaTO CONNECT BLOOD LINES WITH THE BLOOD VESSELS THROUGH NEEDLE WHEN THE DIALYSIS IS CARRIED OUT. (S.No. 178)
MFG/MD/2019/000204 · HaryanaINSERTS 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 · HaryanaALLOWING 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 · HaryanaINTENDED 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 · HaryanaSURGICALS 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 · HaryanaADHESIVE BANDAGES, GAUGE BANDAGES PRESSURE BANDAGES, TRACTION BANDAGES, MEDICAL ABSORBENT (FIBER) BANDAGES. (S.No 332)
MFG/MD/2019/000204 · HaryanaINTENDED FOR MONITORING CENTRAL VENOUS PRESSURE (CVP), SAMPLINGBLOOD AND ADMINISTMTION OF MULTIPLE IV SOLUTION OR DRUGS (S. NO. 61)
MFG/MD/2019/000204 · HaryanaA 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 · HaryanaTHAT 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 · HaryanaA modified fibre optic transducer tipped catheter system for measuring intramuscular pressures during exercise was determined (SR. No. 57)
MFG/MD/2019/000204 · HaryanaTHE 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 · HaryanaCATHETER USE FOR EXCHANGING BLOOD TO AND FROM THE HAEMODIALYSIS MACHINE FORM THE PATIENT (Sr.No. 55)
MFG/MD/2019/000204 · HaryanaTRANSFUSION 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 · HaryanaA BREATHING TUBE INSERTED INTO A TRACHEOTOMY USED TO OBTAIN A CLOSED CIRCUIT FOR VENTILATION (S. NO 29)
MFG/MD/2019/000204 · HaryanaA 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 · HaryanaNEEDLE INSERTED IN BONE MARROW TO COLLECT SAMPLE (S.No. 172)
MFG/MD/2019/000204 · HaryanaINTENDED FOR TRANSIENT DELIVERY OF ANASTHETIC TO PROVIDE REGIONAL ANESTHESIA OR TO FACILITATE PLACEMENT OF AN EPIDURAL CATHETER. (S.No. 179)
MFG/MD/2019/000204 · HaryanaINTENDED 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 · HaryanaALLOWING 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 · HaryanaIT 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 · HaryanaTHE 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 · HaryanaINTERVENTIONAL 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 · HaryanaSUCTION CATHETERS FEATURE A WHISTLE TIP AND A THUMB CONTROL PORT FOR PRECISE AND ACCURATE SUCTIONING (SR. NO. 36)
MFG/MD/2019/000204 · HaryanaIT 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 · HaryanaEXTENSION 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 · HaryanaINTENDED TO PROVIDE EASIER ACCESS TO THE FEMORAL, POPLITEAL AND INFRAPOPLITEAL ARTERIES
MFG/MD/2020/000063It is indicated FOR USE IN PATIENTS REQUIRING ADMINISTRATION OF SOLUTIONS , BLOOD SAMPLING, CENTRAL VENOUS CATHETER, PRESSURE MONITORING AND INJECTION OF CONTRAST MEDIA
MFG/MD/2020/000063A 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/2020/000063Used to absorb extrude of wound and Blood after Surgical Procedure.
MFG/MD/2020/000219 · HaryanaUsed to absorb extrude of wound and Blood after Surgical Procedure.
MFG/MD/2020/000219 · HaryanaIntended to protect an incontinent patient?s garment from patient?s excreta.
MFG/MD/2020/000219 · HaryanaUsed to absorb extrude of wound and Blood after Surgical Procedure.
MFG/MD/2020/000219 · HaryanaUsed to absorb extrude of wound and Blood after Surgical Procedure.
MFG/MD/2020/000219 · HaryanaFor Cleaning of Medical Devices.
MFG/MD/2020/000219 · HaryanaIntended to protect an incontinent patient?s garment from patient?s excreta.
MFG/MD/2020/000219 · HaryanaCATHETER USE FOR EXCHANGING BLOOD TO AND FROM THE HAEMODIALYSIS MACHINE FORM THE PATIENT
MFG/MD/2019/000204 · HaryanaTHE SINGLE-NEEDLE DIALYSIS , IN WHICH CASE ONLY ONE CANNULA OR A SINGLE-LUMEN CATHETER IS USED TO ACCESS THE BLOOD
MFG/MD/2019/000204 · HaryanaTHE SINGLE-NEEDLE DIALYSIS , IN WHICH CASE ONLY ONE CANNULA OR A SINGLE-LUMEN CATHETER IS USED TO ACCESS THE BLOOD
MFG/MD/2019/000204 · HaryanaTHE SINGLE-NEEDLE DIALYSIS , IN WHICH CASE ONLY ONE CANNULA OR A SINGLE-LUMEN CATHETER IS USED TO ACCESS THE BLOOD
MFG/MD/2019/000204 · HaryanaGlobal 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.