Tyvek Rolls - India CDSCO Medical Device Registration

Tyvek Rolls is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2023/000486_63f4556b47c4eb0a6505228ae36e712d_f5009c5bf84ecc9b472fd205a327d868. This device is marketed under the brand name Tyvek Rolls. The license holder is Advanced Sterilization Products India Private Limited, and it is classified as Device Class Class B. The approving authority is CDSCO.

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CDSCO Registered

Class Class B

Tyvek Rolls

UID: IMP/MD/2023/000486_63f4556b47c4eb0a6505228ae36e712d_f5009c5bf84ecc9b472fd205a327d868

Brand Name

Tyvek Rolls

License Holder

Advanced Sterilization Products India Private Limited

Device Class

Class B

Approving Authority

CDSCO

Product Information

Tyvek® Rolls with STERRAD™ Chemical Indicator are intended to be used to enclose medical devices that are to be terminally sterilized in the STERRAD Sterilization Systems and Cycles, in a single or double pouch configuration, and to indicate, by color change, that the pouch has been exposed to sterilant. After completion of the sterilization process, the roll is intended to maintain sterility of the enclosed device until used.