COLTENE Hyflex EDM files - Indonesia BPOM Medical Device Registration
COLTENE Hyflex EDM files is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 10603420412. The device is manufactured by COLTรNE/WHALEDENT GMBH + CO. KG. from Germany, and is classified as Risk Class Kelas Resiko : A. The authorized representative in Indonesia is PT. REVO MEDIKA PARAHYANGAN.
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
COLTรNE/WHALEDENT GMBH + CO. KG.Country of Origin
Germany
Authorized Representative
PT. REVO MEDIKA PARAHYANGANAR Address
Jl. Batununggal Indah II Ruko Blok RD 17 RT.01/RW.05, Desa/Kelurahan Mengger, Kec. Bandung Kidul, Kota Bandung, Provinsi Jawa Barat, Kode Pos: 40267
Registration Date
Dec 22, 2024
Expiry Date
Sep 04, 2029
Product Type
Surgical Dental Equipment
Dental hand instrument
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