Preloaded Monofocal Hydrophobic Aspheric EDOF Lens - India CDSCO Medical Device Registration

Preloaded Monofocal Hydrophobic Aspheric EDOF Lens is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2020/000044_be37f571d04d6f1d1c9b9d5fb93f127d_f13eb65b1851998d3aa174f3ed5b0900. This device is marketed under the brand name BASIC UDI-DI: 8905286HFDR8Q. The license holder is Bio-Tech Vision Care Pvt. Ltd., and it is classified as Device Class Class C. The approving authority is Central Drug Standards Control Organization, Ahmedabad.

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CDSCO Registered

Class Class C

Preloaded Monofocal Hydrophobic Aspheric EDOF Lens

UID: MFG/MD/2020/000044_be37f571d04d6f1d1c9b9d5fb93f127d_f13eb65b1851998d3aa174f3ed5b0900

Brand Name

BASIC UDI-DI: 8905286HFDR8Q

License Holder

Bio-Tech Vision Care Pvt. Ltd.

Device Class

Class C

Approving Authority

Central Drug Standards Control Organization, Ahmedabad

Product Information

It is intended to be implanted into the capsular bag in posterior chamber of the eye for the visual correction of aphakia secondary to the removal of the crystalline lens in patients with cataracts. It is also indicated for presbyopic patients who seek greater independence from glasses for intermediate distances without corneal astigmatism. Patient target group:- Aphakic adult patients (BASIC UDI-DI: 8905286HFDR8Q)