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INVISALIGN Retainers - Indonesia BPOM Medical Device Registration

INVISALIGN Retainers is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20604023286. The device is manufactured by ALIGNTECH DE MEXICO S, DE R.L. DE C. V. from Mexico, 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
INVISALIGN Retainers
Analysis ID: AKL 20604023286

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Country of Origin

Mexico

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 20, 2021

Expiry Date

Apr 13, 2025

Product Type

Therapeutic Dental Equipment

Orthodontic plastic bracket.

Non Electromedic Non Sterile

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