iTero Element 5D Plus - Indonesia BPOM Medical Device Registration
iTero Element 5D Plus is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20602220378. The device is manufactured by ALIGN TECHNOLOGY (SICHUAN) MEDICAL EQUIPMENT CO., LTD from China, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. FONDACO JAYATAMA.
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Risk Classification
Product Class
Kelas : 2
Country of Origin
China
Authorized Representative
PT. FONDACO JAYATAMAAR Address
Agung Podomoro Land Tower, Podomoro City Lt. 27 T1, T2, T5 Jl. Letnan Jendral Siswondo Parman Kav. 28 Kel. Tanjung Duren Selatan, Kec. Grogol Petamburan, Jakarta Barat, DKI Jakarta
Registration Date
Nov 30, 2022
Expiry Date
Mar 23, 2027
Product Type
Prosthetic Dental Equipment
Optical Impression Systems for CAD/CAM.
Non Radiation Electromedics
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