INVISALIGN System Orthodontic Appliance - Indonesia BPOM Medical Device Registration

INVISALIGN System Orthodontic Appliance is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20604320226. 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.

Free Database

BPOM Registered

Risk Class Kelas Resiko : B

INVISALIGN System Orthodontic Appliance

Analysis ID: AKL 20604320226

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Manufacturer

ALIGN TECHNOLOGY (SICHUAN) MEDICAL EQUIPMENT CO. LTD.

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