IRENE Knee Prosthesis - Indonesia BPOM Medical Device Registration
IRENE Knee Prosthesis is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 21302613074. The device is manufactured by TIANJIN ZHENGTIAN MEDICAL INSTRUMENT CO., LTD. from China, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. FAJAR SELARAS PARTNERS.
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Risk Classification
Product Class
Kelas : 2
Manufacturer
TIANJIN ZHENGTIAN MEDICAL INSTRUMENT CO., LTD.Country of Origin
China
Authorized Representative
PT. FAJAR SELARAS PARTNERSAR Address
Komplek Rukan PTC Blok 8C No. 28-29 Pulogadung Tel. 021-46827776 Fax. 021-46827033
Registration Date
Feb 17, 2024
Expiry Date
May 29, 2028
Product Type
Prosthetic Orthopedic Equipment
Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
Non Electromedic Sterile
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IRENE Metal Bone Screws
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