Pure Global

BTK THE SMILE SYSTEM BT SAFE TISSUE - Indonesia BPOM Medical Device Registration

BTK THE SMILE SYSTEM BT SAFE TISSUE is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20602718390. 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 PT. 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.

Free Database
Powered by Pure Global AI
BPOM Registered
Risk Class Kelas Resiko : C
BTK THE SMILE SYSTEM BT SAFE TISSUE
Analysis ID: AKL 20602718390

Risk Classification

Kelas Resiko : C

Product Class

Kelas : 2

Manufacturer

BIOTEC S.R.L.

Country of Origin

Italy

Authorized Representative

PT. PURE NOBLE SUN

AR Address

Jl. Pecenongan No. 82 C Kebon Kelapa, Kec. Gambir Jakarta Pusat 10120

Registration Date

Dec 10, 2020

Expiry Date

Sep 28, 2025

Product Type

Prosthetic Dental Equipment

Endosseous dental implant

Non Electromedic Sterile

Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing