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BTK THE SMILE SYSTEM Is+ Implant - Indonesia BPOM Medical Device Registration

BTK THE SMILE SYSTEM Is+ Implant is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20602420005. The device is manufactured by BIOTEC S.R.L. from Italy, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PURE NOBLE SUN.

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 : C
BTK THE SMILE SYSTEM Is+ Implant
Analysis ID: AKL 20602420005

Risk Classification

Kelas Resiko : C

Product Class

Kelas : 2

Manufacturer

BIOTEC S.R.L.

Country of Origin

Italy

Authorized Representative

PURE NOBLE SUN

AR Address

Jl. Pecenongan No. 82 C, RT.002/RW.004, Kode Pos 10120, Kel. Kebon Kelapa, Kec. Gambir, Kota Adm. Jakarta Pusat, Provinsi DKI Jakarta

Registration Date

Jan 04, 2024

Expiry Date

Sep 28, 2025

Product Type

Prosthetic Dental Equipment

Endosseous dental implant

Non Electromedic Sterile

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