UNITED U2 Hip Stem - Indonesia BPOM Medical Device Registration
UNITED U2 Hip Stem is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 21302711558. The device is manufactured by UNITED ORTHOPEDIC CORPORATION from Taiwan (China), and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. BIOTECH INTI KORPORINDO.
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Risk Classification
Product Class
Kelas : 2
Manufacturer
UNITED ORTHOPEDIC CORPORATIONCountry of Origin
Taiwan (China)
Authorized Representative
PT. BIOTECH INTI KORPORINDOAR Address
Komplek Duta Merlin Blok D11-13 lantai 2 Jl. Gajah Mada No 3-5
Registration Date
Nov 11, 2022
Expiry Date
Aug 29, 2027
Product Type
Prosthetic Orthopedic Equipment
Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.
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USTAR II Surgical Instrument Non Steril
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UNITED Hip System GTF II Stem
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UNITED ORTHOPEDIC Surgical Instrument Non Steril 2
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UNITED U2 Knee System
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UNITED UCP Stem Cemented
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UNITED U2 Total Knee System
UNITED ORTHOPEDIC CORPORATION