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CDSCO UID IMP/MD/2021/000133_30ca4ecd871b923729b07ffa6d1228d6_a0972f8b458f0924766ad871328028fd

Bone Substitute

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·Device Class Class D·India CDSCO·Brand: BIO 1®
Registration details
UID
IMP/MD/2021/000133_30ca4ecd871b923729b07ffa6d1228d6_a0972f8b458f0924766ad871328028fd
Device class
Class D
Brand name
BIO 1®
License holder
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
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
Similar products (3)
Other products with the same name or brand
Bone Substitute
Brand: SmartBone
MEDENTIS DENTAL SOLUTIONS INDIA PRIVATE LIMITED
Class C
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
Class D
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
Class D
Other products from 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
Products from the same license holder (4 products)
Resorbable Interference Screw
Brand: BIO 1®
Class D
Surgical Implants for Synthetic Bone Reconstruction
Brand: OTIS-C/ OTIS-CPLUS/ OTIS-F
Class C
Plate and Screw Fixation System
Brand: OTIS-C/ OTIS-CPLUS/ OTIS-F
Class C
Implant for High Tibial Osteotomy
Brand: BIO 1®
Class D
About this record

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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