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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 COLTรˆNE/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.

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BPOM Registered
Risk Class Kelas Resiko : A
COLTENE Hyflex EDM files
Analysis ID: AKL 10603420412

Risk Classification

Kelas Resiko : A

Product Class

Kelas : 1

Country of Origin

Germany

Authorized Representative

PT. REVO MEDIKA PARAHYANGAN

AR 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

Non Electromedic Sterile

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