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HEDSTROM H-Files - Indonesia BPOM Medical Device Registration

HEDSTROM H-Files is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 10603513918. The device is manufactured by FKG DENTAL SA. from Switzerland, and is classified as Risk Class Kelas Resiko : A. The authorized representative in Indonesia is PT. BINTANG SAUDARA SEMESTA JAYA.

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
HEDSTROM H-Files
Analysis ID: AKL 10603513918

Risk Classification

Kelas Resiko : A

Product Class

Kelas : 1

Manufacturer

FKG DENTAL SA.

Country of Origin

Switzerland

Authorized Representative

PT. BINTANG SAUDARA SEMESTA JAYA

AR Address

Jl.Asia No.212 A-B, Medan

Registration Date

May 06, 2019

Expiry Date

Feb 19, 2024

Product Type

Surgical Dental Equipment

Dental hand instrument.

Non Electromedic Non Sterile

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