IRENE Locking Plate System - Indonesia BPOM Medical Device Registration
IRENE Locking Plate System is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 21302714152. 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
RUKAN PULOGADUNG TRADE CENTRE (PTC) BLOK 8C NOMOR 28-29
Registration Date
Sep 02, 2024
Expiry Date
May 29, 2028
Product Type
Prosthetic Orthopedic Equipment
Single/multiple component metallic bone fixation appliances and accessories.
Non Electromedic Non Sterile
IRENE Spinal Fixation System
IRENE Metal Bone Screws
IRENE Locking Plate System
IRENE Intramedullary Nail System (Titanium)
IRENE Knee Prosthesis
IRENE Locking Plate System
IRENE Locking Plate System
IRENE Metal Bone Screws
IRENE Non-Locking Plate System
IRENE Straight Metal Bone Plates
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