FIXBUTTON Fixation Device - Indonesia BPOM Medical Device Registration
FIXBUTTON Fixation Device is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 21302220185. The device is manufactured by BEIJING DELTA MEDICAL SCIENCE & TECHNOLOGY CORP. LTD. from China, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. PRO-HEALTH INTERNATIONAL.
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Risk Classification
Product Class
Kelas : 2
Country of Origin
China
Authorized Representative
PT. PRO-HEALTH INTERNATIONALAR Address
Komplek Perkantoran Duta Merlin Blok C 35-36 Jalan Gajah Mada 3-5
Registration Date
Apr 23, 2022
Expiry Date
Oct 01, 2026
Product Type
Prosthetic Orthopedic Equipment
Smooth or threaded metallic bone fixation fastener.
Non Electromedic Sterile
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