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Film forming silicone wound dressing - India CDSCO Medical Device Registration

Film forming silicone wound dressing is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2021/000408_25c1fe4de18fa401790c6cb67380c50d_665522c41771c9cb407a32311ce69a43. This device is marketed under the brand name Strata CTX. The license holder is Dr. Reddys Laboratories Limited, and it is classified as Device Class Class B. The approving authority is CDSCO.

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CDSCO Registered
Class Class B
Film forming silicone wound dressing
UID: IMP/MD/2021/000408_25c1fe4de18fa401790c6cb67380c50d_665522c41771c9cb407a32311ce69a43

Brand Name

Strata CTX

Device Class

Class B

Approving Authority

CDSCO

Product Information

StrataXRT is used to relieve low grade inflammatory changes such as dry, itching, flaking, peeling and irritated skin. For more severe inflammatory changes, StrataXRT reduces pain, redness, heat sensation and helps soothe the exposed skin areas. StrataXRT was developed for use on all types of radiation dermatitis, toxic and compromised skin, superficial wounds and burns, including those resulting from: โ€ข Radiation therapy โ€ข First and second degree burns StrataXRT may be applied to superficial wounds, burns and areas where skin integrity has been compromised. StrataXRT may also be used in conjunction with other adjunctive treatments to improve overall results. StrataXRT contains no alcohols, parabens or fragrances and is transparent and odorless. StrataXRT can be used with or without a secondary protective dressing. StrataXRT is suitable for children and people with sensitive skin. StrataXRT is intended for single patient use.

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