iTero Element 2 BVE - Indonesia BPOM Medical Device Registration
iTero Element 2 BVE is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20602124813. 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.
This page provides comprehensive regulatory information including complete registration details, manufacturer information, authorized representative details, product classification, and related products. Pure Global AI offers free access to 67,600+ Indonesia medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.
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
Aug 12, 2022
Expiry Date
May 12, 2026
Product Type
Prosthetic Dental Equipment
Optical Impression Systems for CAD/CAM.
Non Radiation Electromedics
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