Domestic manufacturer · Uttar Pradesh · India

HEALTHIUM MEDTECH PRIVATE LIMITED

CDSCO licensing intelligence, reconciled with the manufacturer’s global footprint · AI-reviewed · expert verification in progress — not yet independently verified.
CDSCO licences
782
Manufacturing
733
Import
49
FDA clearances
0

Risk-class mix (CDSCO)

Class A (low risk)Lowest-risk devices24
Class BLow–moderate risk121
Class CModerate–high risk635
Class D (high risk)Highest-risk devices2

CDSCO device licences

Povidone Iodine Applicator · Class BMFG · 2026-04-21

It is intended for rapid skin antisepsis in pre-operative procedures, surgical site preparation, and invasive procedures. Helps to reduce bacteria on the skin to diminish the risk of surgical site infections.

MFG/MD/2026/000250 · Tamil Nadu
Surface Disinfectant Wipes · Class BMFG · 2026-04-21

THERUPTOR Wipes 70EA is a rapid disinfecting product intended to use medical device disinfection. lt is recommended for use on surfaces such as stainless steel, glass, clean room equipment, and medical devices.

MFG/MD/2026/000250 · Tamil Nadu
Surface Disinfectant Wipes · Class BMFG · 2026-04-21

It is used to disinfect surfaces of non - invasive medical devices and on hard non - porous surfaces of Diagnostic Equipment, Patient monitoring equipment, Dialysis Machines, Ultrasound Probes, Bed railings, IV Poles, Pulse oximeters, ECG, …

MFG/MD/2026/000250 · Tamil Nadu
Surface Disinfectant Wipes · Class BMFG · 2026-04-21

It is used to disinfect surfaces of non - invasive medical devices and on hard non - porous surfaces of Diagnostic Equipment, Patient monitoring equipment, Dialysis Machines, Ultrasound Probes, Bed railings, IV Poles, Pulse oximeters, ECG, …

MFG/MD/2026/000250 · Tamil Nadu
Surgical Incision Film · Class BMFG · 2026-04-21

Theruptor film dressing it is a mechanical barrier to facilitate an operation or procedure. To provide sterile protection to skin surrounding a surgical incision and to maintain surgical sterile environment during operations. It can be used…

MFG/MD/2026/000250 · Tamil Nadu
IV Dressing · Class BMFG · 2026-04-21

Theruptor IV is intended as a dressing to secure devices to skin and also to cover and protect incision sites on the body.

MFG/MD/2026/000250 · Tamil Nadu
Sterile Water Wipes ( To be sterilised) · Class BMFG · 2026-04-21

A Sterile Water Wipes is intended to protect or absorb eye secretion after surgery and affected area.

MFG/MD/2026/000250 · Tamil Nadu
Sterile Absorbent Swab(To be sterilised) · Class AMFG · 2026-04-21

Sterile absorbent swab is intended to be used as a mechanical barrier, for compression or for absorption of exudates only, for wounds which have not breached the dermis and can heal by primary intention.

MFG/MD/2026/000250 · Tamil Nadu
Surface Disinfectant Wipes · Class BMFG · 2026-04-21

Ther Activ-X Wipes are ready-to-use cleaner-disinfectant wipes for healthcare facilities. It is intended to disinfect nonporous hard and soft surfaces (such as MRI, CT, X-Rays, Dialysis, ECG, Stethoscopes, Ultrasound probes, Patient Bed, IV…

MFG/MD/2026/000250 · Tamil Nadu
Surface Disinfectant Solution · Class BMFG · 2026-04-21

It is used to disinfect surfaces of non-invasive medical devices and on hard non-porous surfaces of Diagnostic Equipment, Patient monitoring equipment, Dialysis Machines, Ultrasound Probes, Bed railings, IV Poles, Pulse oximeters, ECG, Stet…

MFG/MD/2026/000250 · Tamil Nadu
Surface Disinfectant Wipes · Class BMFG · 2026-04-21

It is used to disinfect surfaces of non - invasive medical devices and on hard non - porous surfaces of Diagnostic Equipment, Patient monitoring equipment, Dialysis Machines, Ultrasound Probes, Bed railings, IV Poles, Pulse oximeters, ECG, …

MFG/MD/2026/000250 · Tamil Nadu
Surface Disinfectant Solution · Class BMFG · 2026-04-21

It is intended to disinfect nonporous hard and soft surfaces such as MRI, CT, X-Rays, Dialysis, ECG, Stethoscopes, Ultrasound probes, Patient Bed, IV stands, Cleanroom machinery. It can be used for fumigation. It is compatible with a wide r…

MFG/MD/2026/000250 · Tamil Nadu
Disinfectant Wipes · Class BMFG · 2026-04-21

It is intended to be used to disinfect the Medical Devices such as hubs, Connection ports, and others.

MFG/MD/2026/000250 · Tamil Nadu
Disinfectant Wipes · Class BMFG · 2026-04-21

It is intended to be used to disinfect the Medical Devices such as hubs, Connection ports, and others.

MFG/MD/2026/000250 · Tamil Nadu
Surface Disinfectant Wipes · Class BMFG · 2026-04-21

Mikrozid are ready-to-use cleaner-disinfectant wipes. It is intended to disinfect the medical devices.

MFG/MD/2026/000250 · Tamil Nadu
Chlorhexidine Gluconate and Isopropyl Alcohol Applicator · Class BMFG · 2026-04-21

TheraPREP Pro CHG IPA Applicator is intended for rapid skin antisepsis in pre-operative procedures, surgical site preparation, and invasive procedures. Helps to reduce bacteria on the skin to diminish the risk of surgical site infections.

MFG/MD/2026/000250 · Tamil Nadu
Surgical Incision Film · Class BMFG · 2026-04-21

Theruptor IODO-4 is a medicated barrier film to facilitate an operation or procedure. To provide sterile protection to skin surrounding a surgical incision and to maintain surgical sterile environment during operations. It can be used to co…

MFG/MD/2026/000250 · Tamil Nadu
Disinfectant Wipes · Class BMFG · 2026-04-21

It is intended to be used to disinfect the Medical Devices such as hubs, Connection ports, and others.

MFG/MD/2026/000250 · Tamil Nadu
Povidone Iodine Applicator · Class BMFG · 2026-04-21

Nelto 5% PI Swab Applicator is intended for rapid skin antisepsis in the preinjection, pre-operative procedure, surgical site preparation, and invasive procedures. It can be used on sensitive skin like eye and groin areas. It helps to reduc…

MFG/MD/2026/000250 · Tamil Nadu
Sterile Water Wipes (To be sterilized) · Class BMFG · 2026-04-21

A Sterile Water Wipes is intended to protect or absorb eye secretion after surgery and affected area.

MFG/MD/2026/000250 · Tamil Nadu
Cleaner Reagent · Class BMFG · 2026-04-21

It is a cleaning solution based on a unique combination of highly active enzymes for the cleaning of surgical and dental medical equipment such as endoscopes, and surgical and orthopedic instruments. They are suitable for the removal of coa…

MFG/MD/2026/000250 · Tamil Nadu
Surface Disinfectant Wipes · Class BMFG · 2026-04-21

It is used to disinfect surfaces of non - invasive medical devices and on hard non - porous surfaces of Diagnostic Equipment, Patient monitoring equipment, Dialysis Machines, Ultrasound Probes, Bed railings, IV Poles, Pulse oximeters, ECG, …

MFG/MD/2026/000250 · Tamil Nadu
Arthroscopy Instruments (Tool Body-Blades) · Class BIMPORT · 2026-04-01

These are surgical instruments used in arthroscopic surgical procedures.

IMP/MD/2024/000325 · from Italy
Arthroscopy Instruments (Tool Body-Burrs) · Class BIMPORT · 2026-04-01

These are surgical instruments used in arthroscopic surgical procedures.

IMP/MD/2024/000325 · from Italy
Skin Stapler · Class BMFG · 2026-03-26

1. Skin stapler may be used for skin closure in general surgery in a variety of surgical procedures. 2. For closure of uninfected post traumatic wounds. 3. For primary, delayed primary and secondary closure of surgical incisions and wounds.

MFG/MD/2026/000193 · Uttar Pradesh
Surgical Suture Needle · Class BMFG · 2026-03-26

Used for stitching or closing of wounds after invasive surgery or post traumatic wound closure.

MFG/MD/2026/000193 · Uttar Pradesh
Titanium Ligating Clip Applier · Class BMFG · 2026-03-24

Titanium ligating clip appliers are indicated for use as delivery devices for titanium ligating clips. Conformity of the size of the occluded tissue and the clips is required

MFG/MD/2021/000393 · Karnataka
POLYMER LIGATING CLIP APPLIER · Class BMFG · 2026-03-24

Indicated for use on bleeding vessels and leaking tubular structures during open and minimally invasive surgeries.

MFG/MD/2021/000393 · Karnataka
Sterile Skin Staple Remover · Class BMFG · 2026-03-24

Device is indicated for removing of skin staples which were used for wound closure.

MFG/MD/2021/000393 · Karnataka
Arthroscopic Instruments · Class BMFG · 2026-03-10

Arthroscopic Instruments are surgically invasive instruments for manipulating and removing bone and bone fragments. Intended to used in orthoscopic surgical procedure.

MFG/MD/2023/000139 · Gujarat
Tissue Tendon Matrix · Class DIMPORT · 2026-02-06

NeoFlex is indicated for use in sports medicine procedures for the reinforcement and repair of soft tissue where weakness exists, including but not limited to, rotator cuff, patellar, Achilles, biceps, quadriceps and other tendons.

IMP/MD/2026/000093 · from United States
Thick Hydrated Tendon Matrix · Class DIMPORT · 2026-02-06

NeoFlex XL is a surgically implantable surgical mesh device that is intended to be implanted for repair or reinforcement of weak soft tissues.

IMP/MD/2026/000093 · from United States
Skin Stapler · Class BMFG · 2026-01-23

1. Skin stapler may be used for skin closure in general surgery in a variety of surgical procedures. 2. For closure of uninfected post traumatic wounds. 3. For primary, delayed primary and secondary closure of surgical incisions and wounds.

MFG/MD/2026/000049 · Uttar Pradesh
Povidone Iodine Applicator · Class BMFG · 2026-01-23

TheraPREP PI Swab Applicator is intended for rapid skin antisepsis in pre-injection, pre-operative procedure, surgical site preparation, and invasive procedures. Helps to reduce bacteria on the skin to diminish the risk of surgical site inf…

MFG/MD/2026/000052 · Tamil Nadu
Povidone Iodine Applicator · Class BMFG · 2026-01-23

It is intended for rapid skin antisepsis in pre-operative procedures, surgical site preparation, and invasive procedures. Helps to reduce bacteria on the skin to diminish the risk of surgical site infections.

MFG/MD/2026/000052 · Tamil Nadu
Cleaner Reagent · Class BMFG · 2026-01-23

It is a cleaning solution based on a unique combination of highly active enzymes for the cleaning of surgical and dental medical equipment such as endoscopes, and surgical and orthopedic instruments. They are suitable for the removal of coa…

MFG/MD/2026/000052 · Tamil Nadu
Surface Disinfectant Wipes · Class BMFG · 2026-01-23

It is used to disinfect surfaces of non - invasive medical devices and on hard non - porous surfaces of Diagnostic Equipment, Patient monitoring equipment, Dialysis Machines, Ultrasound Probes, Bed railings, IV Poles, Pulse oximeters, ECG, …

MFG/MD/2026/000052 · Tamil Nadu
Surgical Incision Film · Class BMFG · 2026-01-23

Theruptor film dressing it is a mechanical barrier to facilitate an operation or procedure. To provide sterile protection to skin surrounding a surgical incision and to maintain surgical sterile environment during operations. It can be used…

MFG/MD/2026/000052 · Tamil Nadu
Disinfectant Wipes · Class BMFG · 2026-01-23

It is intended to be used to disinfect the Medical Devices such as hubs, Connection ports, and others.

MFG/MD/2026/000052 · Tamil Nadu
Disinfectant Wipes · Class BMFG · 2026-01-23

It is intended to be used to disinfect the Medical Devices such as hubs, Connection ports, and others.

MFG/MD/2026/000052 · Tamil Nadu
Chlorhexidine Gluconate and Isopropyl Alcohol Applicator · Class BMFG · 2026-01-23

TheraPREP CHG IPA Swab Applicator is intended for rapid skin antisepsis in preinjection, pre-operative procedure, surgical site preparation, and invasive procedures. Helps to reduce bacteria on the skin to diminish the risk of surgical site…

MFG/MD/2026/000052 · Tamil Nadu
IV Dressing · Class BMFG · 2026-01-23

Theruptor IV is intended as a dressing to secure devices to skin and also to cover and protect incision sites on the body.

MFG/MD/2026/000052 · Tamil Nadu
Surface Disinfectant Solution · Class BMFG · 2026-01-23

It is intended to disinfect nonporous hard and soft surfaces such as MRI, CT, XRays, Dialysis, ECG, Stethoscopes, Ultrasound probes, Patient Bed, IV stands, Cleanroom machinery. It can be used for fumigation. It is compatible with a wide ra…

MFG/MD/2026/000052 · Tamil Nadu
Chlorhexidine Gluconate and Isopropyl Alcohol Applicator · Class BMFG · 2026-01-23

TheraPREP Pro CHG IPA Applicator is intended for rapid skin antisepsis in preoperative procedures, surgical site preparation, and invasive procedures. Helps to reduce bacteria on the skin to diminish the risk of surgical site infections.

MFG/MD/2026/000052 · Tamil Nadu
Surgical Incision Film · Class BMFG · 2026-01-23

Theruptor IODO-4 is a medicated barrier film to facilitate an operation or procedure. To provide sterile protection to skin surrounding a surgical incision and to maintain surgical sterile environment during operations. It can be used to co…

MFG/MD/2026/000052 · Tamil Nadu
Surface Disinfectant Solution · Class BMFG · 2026-01-23

It is used to disinfect surfaces of non-invasive medical devices and on hard nonporous surfaces of Diagnostic Equipment, Patient monitoring equipment, Dialysis Machines, Ultrasound Probes, Bed railings, IV Poles, Pulse oximeters, ECG, Steth…

MFG/MD/2026/000052 · Tamil Nadu
Surface Disinfectant Wipes · Class BMFG · 2026-01-23

TherActiv-X Wipes are ready-to-use cleaner-disinfectant wipes for healthcare facilities. It is intended to disinfect nonporous hard and soft surfaces (such as MRI, CT, X-Rays, Dialysis, ECG, Stethoscopes, Ultrasound probes, Patient Bed, IV …

MFG/MD/2026/000052 · Tamil Nadu
Sterile Surgical Latex Gloves · Class BMFG · 2025-11-28

The Sterile Latex Surgical Gloves ? Pre-powdered / or Powder free are made of natural rubber latex, intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants. T…

MFG/MD/2022/000387 · Karnataka
Sterile Skin Stapler · Class BMFG · 2025-11-28

1. Sterile skin stapler may be used for skin closure in general surgery in a variety of surgical procedures. 2. For closure of uninfected post traumatic wounds. 3. For primary, delayed primary and secondary closure of surgical incisions and…

MFG/MD/2021/000393 · Karnataka
Surgical Suture Needle- Spring Eye · Class AMFG · 2025-11-28

Surgical Suture Needle- Spring Eye Used to make a piercing while suturing the wound in combination with the suture thread.

MFG/MD/2021/000393 · Karnataka

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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