FIBER-SPLINT - Indonesia BPOM Medical Device Registration
FIBER-SPLINT is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 10602913793. The device is manufactured by POLYDENTIA SA from Switzerland, and is classified as Risk Class Kelas Resiko : A. 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 : 1
Manufacturer
POLYDENTIA SACountry of Origin
Switzerland
Authorized Representative
PT. PURE NOBLE SUNAR Address
Jl. Pecenongan No. 82 C Kebon Kelapa, Kec. Gambir Jakarta Pusat 10120
Registration Date
Jan 20, 2021
Expiry Date
Dec 31, 2023
Product Type
Prosthetic Dental Equipment
Retentive and splinting pin.
Non Electromedic Non Sterile
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