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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.

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BPOM Registered
Risk Class Kelas Resiko : B
iTero Element 2 BVE
Analysis ID: AKL 20602124813

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

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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