Bone Plate - India CDSCO Medical Device Registration

Bone Plate is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2019/000061_3d18736f7e1d94ec1c52f33e2e890dda_3ba10024196b1d5d000d236dd645aa85. This device is marketed under the brand name Fix/Mobile/Revision System And Tumor System. The license holder is SMIT MEDIMED PVT LTD, and it is classified as Device Class Class C. The approving authority is Central Drug Standards Control Organization, Ahmedabad.

This page provides comprehensive regulatory information including complete registration details, license holder information, device classification, and related products. Pure Global AI offers free access to 71,807+ India medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.

Free Database

CDSCO Registered

Class Class C

Bone Plate

UID: MFG/MD/2019/000061_3d18736f7e1d94ec1c52f33e2e890dda_3ba10024196b1d5d000d236dd645aa85

Brand Name

Fix/Mobile/Revision System And Tumor System

License Holder

SMIT MEDIMED PVT LTD

Device Class

Class C

Approving Authority

Central Drug Standards Control Organization, Ahmedabad

Product Information

The bone plate is intended to use for internal fixation of fractures and reconstruction of bones including the scapula, olecranon, Humerus, radius, ulna, pelvis, tibia, fibula, femoral. Examples of these internal fixations and reconstructions include compression fractures, intra-articular and extra articular fractures, displaced fractures, osteotomies, non-unions and mal-unions. This system can be used for ventral, dorsal or orthogonal applications.

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing

Brand: SMPL

Class A