Sclerotome - India CDSCO Medical Device Registration

Sclerotome is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2023/000446_d17b7146b52ea5cf2bb1a8944915a737_7af1257c55afffea7611164af356f7d3. This device is marketed under the brand name SURGI EDGE. The license holder is SURGI EDGE INDIA, and it is classified as Device Class Class A. The approving authority is Gujarat.

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CDSCO Registered

Class Class A

Sclerotome

UID: MFG/MD/2023/000446_d17b7146b52ea5cf2bb1a8944915a737_7af1257c55afffea7611164af356f7d3

Brand Name

SURGI EDGE

License Holder

SURGI EDGE INDIA

Device Class

Class A

Approving Authority

Gujarat

Product Information

A hand-held manual ophthalmic surgical instrument that is knife-like in design and intended to be used to incise the sclera during a sclerotomy

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Eye Cup

Brand: SURGI EDGE

SURGI EDGE INDIA

Sclerotome - India CDSCO Medical Device Registration

Brand Name

License Holder

Device Class

Approving Authority

Product Information

DJ Fang

Eye Cup

CORNEAL TREPHINE

Fibreoptic General-Purpose Ophthalmic Hook

Eye Irrigation Shield

OPHTHALMIC STRIPS

SURGICAL KIT

IRIS RETRACTOR

Ophthalmic Head Reflector

Ophthalmic Surgical Device Handling Forceps

VITERECTOMY TROCAR

Eye Cup

OPHTHALMIC CANNULA

CORNEAL TREPHINE

Fibreoptic General-Purpose Ophthalmic Hook

SURGICAL SHIELD/EYE SHIELD/ELBOW SHIELD/BODY SHIELD

Eye Irrigation Shield

OPHTHALMIC STRIPS

SURGICAL KIT

VITRECTOMY CUTTER

IRIS RETRACTOR