Pure Global

Tissue Sealing Device(ENSEAL ) - India CDSCO Medical Device Registration

Tissue Sealing Device(ENSEAL ) is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2020/000009_4553426d4d015b5f36ea6ffb16e6fc85_5fb2869c1a49fde0b66005827e241753. This device is marketed under the brand name Shears with Advanced Hemostasis . The license holder is Johnson & Johnson Private Limited ,A-1/ 50, Room No. 2, 100 Shed Area, G.l.D.C., Vapi, Tal Pardi (Valsad) ,Valsad Gujarat ,396195 ,India, and it is classified as Device Class Class D. The approving authority is CDSCO.

This page provides comprehensive regulatory information including complete registration details, license holder information, device classification, and related products. Pure Global AI offers free access to 71,807+ India medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.

Free Database
Powered by Pure Global AI
CDSCO Registered
Class Class D
Tissue Sealing Device(ENSEAL )
UID: IMP/MD/2020/000009_4553426d4d015b5f36ea6ffb16e6fc85_5fb2869c1a49fde0b66005827e241753

Brand Name

Shears with Advanced Hemostasis

Device Class

Class D

Approving Authority

CDSCO

Product Information

The ENSEALยฎ G2 Tissue Sealers are indicated for bipolar coagulation and mechanical transection of tissue during laparoscopic and open procedures. The devices are bipolar electrosurgical instruments for use with an electrosurgical generator. They are intended for use during open or laparoscopic, general and gynecological surgery to cut and seal vessels, and to cut, grasp and dissect tissue during surgery. Indications for use include open and laparoscopic, general and gynecological surgical procedures (Shears with Advanced Hemostasis ), or any procedure where vessel ligation (Shears with Advanced Hemostasis ), tissue grasping and dissection is performed. The devices can be used on vessels up to (Shears with Advanced Hemostasis ) 7 mm and bundles as large as will fit in the jaws of the instruments. The ENSEALยฎ G2 Tissue Sealers have not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use these devices for these procedures

Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Similar Products (10)
Other products with the same name or brand

Electrosurgery Probe

Brand: Shears with Advanced Hemostasis

Johnson & Johnson Private Limited ,A-1/ 50, Room No. 2, 100 Shed Area, G.l.D.C., Vapi, Tal Pardi (Valsad) ,Valsad Gujarat ,396195 ,India

Class D

Ablation Device(Harmonic FOCUS )

Brand: Shears with Advanced Hemostasis

Johnson & Johnson Private Limited ,A-1/ 50, Room No. 2, 100 Shed Area, G.l.D.C., Vapi, Tal Pardi (Valsad) ,Valsad Gujarat ,396195 ,India

Class D

Tissue Sealing Device(Enseal )

Brand: Shears with Advanced Hemostasis

Johnson & Johnson Private Limited ,A-1/ 50, Room No. 2, 100 Shed Area, G.l.D.C., Vapi, Tal Pardi (Valsad) ,Valsad Gujarat ,396195 ,India

Class D

Ablation Device(Harmonic)

Brand: Shears with Advanced Hemostasis

Johnson & Johnson Private Limited ,A-1/ 50, Room No. 2, 100 Shed Area, G.l.D.C., Vapi, Tal Pardi (Valsad) ,Valsad Gujarat ,396195 ,India

Class D

Ablation Device(Harmonic)

Brand: Shears with Advanced Hemostasis

Johnson & Johnson Private Limited ,A-1/ 50, Room No. 2, 100 Shed Area, G.l.D.C., Vapi, Tal Pardi (Valsad) ,Valsad Gujarat ,396195 ,India

Class D

Ablation Device(Harmonic ACE )

Brand: Shears with Advanced Hemostasis

Johnson & Johnson Private Limited ,A-1/ 50, Room No. 2, 100 Shed Area, G.l.D.C., Vapi, Tal Pardi (Valsad) ,Valsad Gujarat ,396195 ,India

Class D

Ablation Device(Harmonic ACE )

Brand: Shears with Advanced Hemostasis

Johnson & Johnson Private Limited ,A-1/ 50, Room No. 2, 100 Shed Area, G.l.D.C., Vapi, Tal Pardi (Valsad) ,Valsad Gujarat ,396195 ,India

Class D

Ablation Device(Harmonic ACE)

Brand: Shears with Advanced Hemostasis

Johnson & Johnson Private Limited ,A-1/ 50, Room No. 2, 100 Shed Area, G.l.D.C., Vapi, Tal Pardi (Valsad) ,Valsad Gujarat ,396195 ,India

Class D

Tissue Sealing Device(ENSEAL )

Brand: Shears with Advanced Hemostasis

Johnson & Johnson Private Limited ,A-1/ 50, Room No. 2, 100 Shed Area, G.l.D.C., Vapi, Tal Pardi (Valsad) ,Valsad Gujarat ,396195 ,India

Class D

Tissue Sealing Device(ENSEAL )

Brand: Shears with Advanced Hemostasis

Johnson & Johnson Private Limited ,A-1/ 50, Room No. 2, 100 Shed Area, G.l.D.C., Vapi, Tal Pardi (Valsad) ,Valsad Gujarat ,396195 ,India

Class D
Other Products from Johnson & Johnson Private Limited ,A-1/ 50, Room No. 2, 100 Shed Area, G.l.D.C., Vapi, Tal Pardi (Valsad) ,Valsad Gujarat ,396195 ,India
Products from the same license holder (10 products)