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/2022/000502_d5ccb723859fb662602a40965733f9d7_a3e1ce42f0abd9d0cf4e5ec6639bbbf8. This device is marketed under the brand name Biological skin dressing. The license holder is SynerHeal Pharmaceuticals, and it is classified as Device Class Class D. The approving authority is Central Drug Standard Control Organisation, South Zone.
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Brand Name
Biological skin dressing
License Holder
SynerHeal PharmaceuticalsDevice Class
Approving Authority
Central Drug Standard Control Organisation, South Zone
Product Information
Sterile Collagen Sheet (Biological skin dressing) is intended for use in the management of wounds. Wound types include: • Non-infected second-degree burns • Third degree burns as a temporary cover after Escharectomy/Tangential Excision • Skin Donor Sites • Traumatic loss of Skin Cover • Temporary wound cover in major open fractures before definitive flap cover • Partial and full-thickness wounds, • Pressure ulcers, • Venous ulcers, • Diabetic ulcers, • Chronic vascular ulcers, • Surgical wounds (Biological skin dressing), • Trauma wounds (Biological skin dressing)
