CDSCO UID IMP/MD/2023/001013_ece2f7f9e65d18ec6e2bfa1fd1ce2ad6_f32643a970dd6c3dbebb28408b02f8d5

MAMMARY IMPLANT SILICONE GEL – POLYURETHANE FOAM COATED SURFACE

NK Healthcare Pvt. Ltd·Device Class Class C·India CDSCO·Brand: Silimed
Registration details
UID
IMP/MD/2023/001013_ece2f7f9e65d18ec6e2bfa1fd1ce2ad6_f32643a970dd6c3dbebb28408b02f8d5
Device class
Class C
Brand name
Silimed
Approving authority
CDSCO
Product information
SILIMED Silicone Gel Mammary Implants achieve their intended purpose in the following ways: - in case of breast enlargement: increased volume and circumference of one or both breasts; - in the case of breast reconstruction: return of the volume and circumference of one or both breasts removed after mastectomy or trauma or not developed due to any medical abnormality. SILIMED Mammary Implant is a single-use product implantable through invasive surgery and its medical grade silicone elastomer composition and polyurethane foam lining, where applicable, come into contact with breast tissues for a prolonged use of the implant.
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About this record

MAMMARY IMPLANT SILICONE GEL – POLYURETHANE FOAM COATED SURFACE is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2023/001013_ece2f7f9e65d18ec6e2bfa1fd1ce2ad6_f32643a970dd6c3dbebb28408b02f8d5. This device is marketed under the brand name Silimed. The license holder is NK Healthcare Pvt. Ltd, and it is classified as Device Class Class C. The approving authority is CDSCO.

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