OSTHYONE Knee Arthroplasty Instrument - Indonesia BPOM Medical Device Registration
OSTHYONE Knee Arthroplasty Instrument is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 11303420032. The device is manufactured by SHENZHEN BONE MEDICAL DEVICES CO., LTD. from China, and is classified as Risk Class Kelas Resiko : A. The authorized representative in Indonesia is PT. MAGNIFICENT DINAR CALAKAN.
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Risk Classification
Product Class
Kelas : 1
Manufacturer
SHENZHEN BONE MEDICAL DEVICES CO., LTD.Country of Origin
China
Authorized Representative
PT. MAGNIFICENT DINAR CALAKANAR Address
Jl. Danita 2 Kav 2 RT 015 RW 013, Kel. Bekasijaya, Kec. Bekasi Timur, Kota Bekasi, Jawa Barat
Registration Date
Jan 31, 2024
Expiry Date
Feb 23, 2026
Product Type
Surgical Orthopaedic Equipment
Orthopedic manual surgical instrument.
Non Electromedic Non Sterile
OSTEOPRIME Hip Prostheses
OSTEOPRIME Knee Prostheses
OSTHYONE Hip Arthroplasty Instrument
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OSTHYONE Hip Prostheses
OSTHYONE Knee Prostheses
FIXAMET Knee Arthroplasty Device Set
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