Kit(Penumbra System- Penumbra Jet 7 Reperfusion Catheter Standard Tip Kit ) - India CDSCO Medical Device Registration

Kit(Penumbra System- Penumbra Jet 7 Reperfusion Catheter Standard Tip Kit ) is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2019/000544_0e6b676c88c9dfc7a0aa9853f6804b2e_0e1bec8e6e7181babc965c1e295cd189. This device is marketed under the brand name Kit. The license holder is M/S ASIA ACTUAL INDIA (OPC) PVT. LTD., and it is classified as Device Class Class D. The approving authority is CDSCO.

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CDSCO Registered

Class Class D

Kit(Penumbra System- Penumbra Jet 7 Reperfusion Catheter Standard Tip Kit )

UID: IMP/MD/2019/000544_0e6b676c88c9dfc7a0aa9853f6804b2e_0e1bec8e6e7181babc965c1e295cd189

Brand Name

Kit

License Holder

M/S ASIA ACTUAL INDIA (OPC) PVT. LTD.

Device Class

Class D

Approving Authority

CDSCO

Product Information

As part of the Penumbra System, the Reperfusion Catheters and Separators are indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (Kit) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (Kit) or who fail IV t-PA therapy are candidates for treatment. As part of the Penumbra System, the Penumbra Sterile Aspiration Tubing is indicated to connect the Penumbra Reperfusion Catheters to the Penumbra Aspiration Pump

Class D

Aspiration Catheter

Brand: Kit

M/S ASIA ACTUAL INDIA (OPC) PVT. LTD.

Class D

Brand: Atrial Fibrillation History Feature

Class B