Harmonic Adaptor - India CDSCO Medical Device Registration

Harmonic Adaptor is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2023/000258_23f513ecdf83ae244ca2dc4250e6dabe_ee970a80f851540c7f74cdb6f36fa658. This device is marketed under the brand name Harmonic. The license holder is Johnson & Johnson Private Limited, and it is classified as Device Class Class B. The approving authority is CDSCO.

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CDSCO Registered

Class Class B

Harmonic Adaptor

UID: IMP/MD/2023/000258_23f513ecdf83ae244ca2dc4250e6dabe_ee970a80f851540c7f74cdb6f36fa658

Brand Name

Harmonic

License Holder

Johnson & Johnson Private Limited

Device Class

Class B

Approving Authority

CDSCO

Product Information

Verify compatibility of all instruments and accessories prior to using the instrument (Harmonic). Before using the Harmonic Disposable Hand Switching Adaptor, inspect the package for general packaging integrity. If the packaging appears to have been opened or damaged, do not use or attempt to reserialize. The Disposable Hand Switching Adaptor is compatible with the following Harmonic System components: Generator, Hand Piece and 5 mm instrument blades. The Hand Switching Adaptor is not compatible with Harmonic Shears, 10 mm instrument blades, and Blue Hand Piece.

Class C

Tissue Sealing Device

Brand: Harmonic

Johnson & Johnson Private Limited

Class C

Brand: PROLENE*

Class D