OSTHYONE Knee Prostheses - Indonesia BPOM Medical Device Registration
OSTHYONE Knee Prostheses is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 21302320680. The device is manufactured by SHENZHEN BONE MEDICAL DEVICES CO., LTD. from China, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. MAGNIFICENT DINAR CALAKAN.
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Risk Classification
Product Class
Kelas : 2
Manufacturer
SHENZHEN BONE MEDICAL DEVICES CO., LTD.Country of Origin
China
Authorized Representative
PT. MAGNIFICENT DINAR CALAKANAR Address
Citra Swarna Regency, Jalan Melati Raya Barat
Registration Date
May 20, 2023
Expiry Date
May 18, 2026
Product Type
Prosthetic Orthopedic Equipment
Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
Non Electromedic Non Sterile
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