Bone Substitute - India CDSCO Medical Device Registration
Bone Substitute is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2021/000133_30ca4ecd871b923729b07ffa6d1228d6_a0972f8b458f0924766ad871328028fd. This device is marketed under the brand name BIO 1®. The license holder is EURO MEDI TOOLS PRIVATE LIMITED ,ONE HALL ON FIRST FLOOR PROPERTY NO A-54, FIEE COMPLEX, PHASE-2, OKHLA IND. AREA, NEW DELHI ,South Delhi Delhi ,110020 ,India, and it is classified as Device Class Class D. The approving authority is CDSCO.
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Brand Name
BIO 1®
Device Class
Approving Authority
CDSCO
Product Information
BIO-1® are absorbable calcium salt bone void fillers intended to fill bony voids or gaps of the skeletal system (BIO 1®) caused by trauma or surgery, that are not intrinsic to the stability of the bony structure. BIO-1® bone substitutes do not possess sufficient mechanical strength to support the reduction of a defect prior to complete bone healing. Rigid fixation techniques must be used to ensure stabilization of the defect in all planes
Bone Substitute
Brand: SmartBone
MEDENTIS DENTAL SOLUTIONS INDIA PRIVATE LIMITED
Resorbable Interference Screw
Brand: BIO 1®
EURO MEDI TOOLS PRIVATE LIMITED ,ONE HALL ON FIRST FLOOR PROPERTY NO A-54, FIEE COMPLEX, PHASE-2, OKHLA IND. AREA, NEW DELHI ,South Delhi Delhi ,110020 ,India
Implant for High Tibial Osteotomy
Brand: BIO 1®
EURO MEDI TOOLS PRIVATE LIMITED ,ONE HALL ON FIRST FLOOR PROPERTY NO A-54, FIEE COMPLEX, PHASE-2, OKHLA IND. AREA, NEW DELHI ,South Delhi Delhi ,110020 ,India