Expandable Introducer Sheath - India CDSCO Medical Device Registration

Expandable Introducer Sheath is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2020/000086_6db5f5eead232c76243404bcf94e38a0_bed7c36f5960b36d9890596d6bfb121b. This device is marketed under the brand name Expanse sheath/ Guide sheath/ Large path. The license holder is Relisys Medical Devices Limited, and it is classified as Device Class Class C. The approving authority is CDSCO, Zonal office, Hyderabad.

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CDSCO Registered

Class Class C

Expandable Introducer Sheath

UID: MFG/MD/2020/000086_6db5f5eead232c76243404bcf94e38a0_bed7c36f5960b36d9890596d6bfb121b

Brand Name

Expanse sheath/ Guide sheath/ Large path

License Holder

Relisys Medical Devices Limited

Device Class

Class C

Approving Authority

CDSCO, Zonal office, Hyderabad

Product Information

The Expandable Introducer sheath is intended for introduction of interventional devices into the vascular system. The product is intended for use by physicians trained and experienced in interventional techniques. Standard techniques for placement of vascular access sheaths should be employed