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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_1b0093fc352d2d01b9c0d88805959437. 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_1b0093fc352d2d01b9c0d88805959437

Brand Name

Strata CTX

Device Class

Class B

Approving Authority

CDSCO

Product Information

StrataCTX is used to relieve low grade inflammatory changes such as dry, itching, flaking, peeling and irritated skin. For more severe inflammatory changes, StrataCTX reduces pain, redness and heat sensation. StrataCTX was developed for use on all types of wounds, toxic and compromised skin including: โ€ข Cutaneous reactions โ€ข Pruritic, itchy skin โ€ข Xerotic, dry skin โ€ข Desquamation โ€ข Fissures of skin and nail folds โ€ข Blisters โ€ข Medical Adhesive-Related Skin Injuries (Strata CTX) โ€ข Erythema โ€ข Infusion reactions โ€ข Rashes, including: Maculopapular rash, hand-foot syndrome, GVHD, acneiform reaction, peri โ€“ and appendageal (Strata CTX). StrataCTX can be used with or without a secondary protective dressing. StrataCTX is suitable for children and people with sensitive skin. StrataCTX is intended for single patient use. StrataCTX is ideal for large surface areas and contoured skin like head, face, hand and foot, as well as joints and hairy areas without the need for shaving. StrataCTX is transparent allowing users to monitor therapy progress without removal of the dressing

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