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CDSCO UID IMP/MD/2020/000473_dff72e7aaa72971a797c0ebea972c3f0_55fef153ad6f46535054e934c269d16c

Delivery System

Encarta Pharma Pvt. Ltd.·Device Class Class B·India CDSCO·Brand: Softject
Registration details
UID
IMP/MD/2020/000473_dff72e7aaa72971a797c0ebea972c3f0_55fef153ad6f46535054e934c269d16c
Device class
Class B
Brand name
Softject
License holder
Encarta Pharma Pvt. Ltd.
Approving authority
CDSCO
Product information
The SoftJect delivery system is an ophthalmic device, used during cataract surgery. It is used for insertion and implantation of a foldable one-piece intraocular lens (Softject) through an incision in the cornea. The standard procedure includes folding the IOL into the cartridge and injection into the capsular bag following capsular cataract extraction. The Softject 2.4-1P is intended for an incision size of <2.4 mm. The Softject 1.8-1P is intended for an incision size of <1.8 mm.
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About this record

Delivery System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2020/000473_dff72e7aaa72971a797c0ebea972c3f0_55fef153ad6f46535054e934c269d16c. This device is marketed under the brand name Softject. The license holder is Encarta Pharma Pvt. Ltd., and it is classified as Device Class Class B. The approving authority is CDSCO.

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