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Saturn Bipolar Cup - India CDSCO Medical Device Registration

Saturn Bipolar Cup is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID PD-112_4fa14717ce6d6f28da42bd6ae647f687_3472cd780884bd896d3f3b6af133740f. This device is marketed under the brand name PITKAR. The license holder is S.H.Pitkar Orthotools Pvt. Ltd., and it is classified as Device Class Class D. The approving authority is Central Drug Standards Control Organization, West Zone.

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.

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CDSCO Registered
Class Class D
Saturn Bipolar Cup
UID: PD-112_4fa14717ce6d6f28da42bd6ae647f687_3472cd780884bd896d3f3b6af133740f

Brand Name

PITKAR

Device Class

Class D

Approving Authority

Central Drug Standards Control Organization, West Zone

Product Information

The Bipolar Cup is for uncemented use in conjunction with a standard cemented or uncemented femoral replacement implant for the following: a. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis b. Rheumatoid arthritis c. Correction of functional deformity d. Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques

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