BTK THE SMILE SYSTEM Mini Implant - Indonesia BPOM Medical Device Registration
BTK THE SMILE SYSTEM Mini Implant is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20602718387. 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.
Risk Classification
Product Class
Kelas : 2
Manufacturer
BIOTEC S.R.L.Country of Origin
Italy
Authorized Representative
PT. PURE NOBLE SUNAR Address
Jl. Pecenongan No. 82 C Kebon Kelapa, Kec. Gambir Jakarta Pusat 10120
Registration Date
Dec 15, 2020
Expiry Date
Sep 28, 2025
Product Type
Prosthetic Dental Equipment
Endosseous dental implant
Non Electromedic Sterile
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