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Silicone Oil 5000 mm2/s Intraocular Endotamponade for Domestic and Export - India CDSCO Medical Device Registration

Silicone Oil 5000 mm2/s Intraocular Endotamponade for Domestic and Export is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2019/000225_cae8ce8bc4449c4d7cd1f8e21468d5f0_d5b87f96bd2fb4169000c9d18e62d7ae. This device is marketed under the brand name -----. The license holder is AUROLAB, and it is classified as Device Class Class C. The approving authority is Central Drug Standard Control Organisation, South Zone.

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CDSCO Registered
Class Class C
Silicone Oil 5000 mm2/s Intraocular Endotamponade for Domestic and Export
UID: MFG/MD/2019/000225_cae8ce8bc4449c4d7cd1f8e21468d5f0_d5b87f96bd2fb4169000c9d18e62d7ae

Brand Name

-----

License Holder

AUROLAB

Device Class

Class C

Approving Authority

Central Drug Standard Control Organisation, South Zone

Product Information

Silicone Oil 5000cSt is indicated for use as a prolonged retinal tamponade in selected cases of complicated retinal detachments where other interventions are not appropriate for patient management. Complicated retinal detachments or recurrent retinal detachments occur most commonly in eyes with proliferative vitreoretinopathy (-----), Proliferative diabetic retinopathy (-----), Cytomegalovirus (-----) retinitis, Giant tears and following perforating injuries. Silicone Oil 5000cSt is also indicated for primary use in detachments due to AIDS related CMV retinitis and other viral infections affecting the retina. It is intended for intraocular use only

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