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ITERO Element 5D e-oral scanner - Indonesia BPOM Medical Device Registration

ITERO Element 5D e-oral scanner is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20602420029. 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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BPOM Registered
Risk Class Kelas Resiko : B
ITERO Element 5D e-oral scanner

ITERO Element 5D intra-oral scanner

Analysis ID: AKL 20602420029

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Country of Origin

China

Authorized Representative

PT. FONDACO JAYATAMA

AR 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

Jan 17, 2024

Expiry Date

Jan 05, 2027

Product Type

Prosthetic Dental Equipment

Optical Impression Systems for CAD/CAM.

Non Radiation Electromedics

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