DISPOSABLE NEO EYE SHIELD FOR UV PROTECTION PHOTOTHERAPY - India CDSCO Medical Device Registration

DISPOSABLE NEO EYE SHIELD FOR UV PROTECTION PHOTOTHERAPY is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2023/000151_938e1aef4bac08e1384e8bb717493b59_b965b77ae4caa26a3dc3f79a683c3569. This device is marketed under the brand name NEO SPLINTY. The license holder is NEW CARE HYGIENE PRODUCTS, and it is classified as Device Class Class A. The approving authority is Kerala.

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CDSCO Registered

Class Class A

DISPOSABLE NEO EYE SHIELD FOR UV PROTECTION PHOTOTHERAPY

UID: MFG/MD/2023/000151_938e1aef4bac08e1384e8bb717493b59_b965b77ae4caa26a3dc3f79a683c3569

Brand Name

NEO SPLINTY

License Holder

NEW CARE HYGIENE PRODUCTS

Device Class

Class A

Approving Authority

Kerala

Product Information

A device worn to cover and protect the eyes of a patient from potentially harmful rays [e.g., ultraviolet (NEO SPLINTY) to which their body is intentionally exposed during light therapy treatment. It will typically be designed as a mechanical mask-like shield with properties to block or inhibit the transmission of rays to the eyes. It will typically be made of soft materials in a variety of sizes, e.g., premature infant, neonatal and affix to the head using bands, hooks, Velcro fasteners, and/or adhesive fasteners. This is a single-use device.