Hemodialysis Catheter - India CDSCO Medical Device Registration

Hemodialysis Catheter is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2019/000042_d0bf0ea016db6464967ac4fe570cfdff_f008e726bf5bc380ed52d730b1702892. This device is marketed under the brand name Asteria. The license holder is Dolphin Lifescience India LLP, and it is classified as Device Class Class C. The approving authority is Central Drug Standards Control Organization, Ahmedabad.

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CDSCO Registered

Class Class C

Hemodialysis Catheter

UID: MFG/MD/2019/000042_d0bf0ea016db6464967ac4fe570cfdff_f008e726bf5bc380ed52d730b1702892

Brand Name

Asteria

License Holder

Dolphin Lifescience India LLP

Device Class

Class C

Approving Authority

Central Drug Standards Control Organization, Ahmedabad

Product Information

Haemodialysis Catheters are the sterile, single use range of short-term use polyurethane catheters designed to facilitate infusion or haemodialysis therapy in a critical care environment. The Catheter is surgically penetrated into the central vena or vena cava superior or vena cava inferior of the body via Seldinger Technique. It is possible to be inserted inside the body for less than 30days. It may be applicable to the one of following therapy: - To supply the temporary blood vessel access in haemodialysis treatment; - Monitor of central venous pressure; - Continuous or discontinuous venous transfusion