Sterile Collagen Sheet - India CDSCO Medical Device Registration
Sterile Collagen Sheet is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2023/000337_d5ccb723859fb662602a40965733f9d7_2d04b5c3a6c305864f195f882bffe989. This device is marketed under the brand name non-infected. The license holder is Microtrol Sterilisation Services Pvt Ltd, and it is classified as Device Class Class D. The approving authority is Sub Zonal Bangalore.
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Brand Name
non-infected
License Holder
Microtrol Sterilisation Services Pvt LtdDevice Class
Approving Authority
Sub Zonal Bangalore
Product Information
A sterile Collagen Sheet (non-infected) is intended for use in the management of wounds. Wound types include: • Non-infected second-degree burns • Venous Ulcers • Diabetic Ulcers • Chronic vascular Ulcers • Pressure Ulcers • Third-degree burns as a temporary cover after Escharectomy/ Tangenital Excision • Skin donor sites • Traumatic loss of skin cover • Temporary wound cover in major open fractures before definitive flap cover • Surgical wounds(non-infected) • Partial and full-thickness wounds • Trauma wounds (non-infected)
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