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DENJOY i3 Gold Rotary File - Indonesia BPOM Medical Device Registration

DENJOY i3 Gold Rotary File is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 10603918365. The device is manufactured by DENJOY DENTAL CO., LTD. from China, and is classified as Risk Class Kelas Resiko : A. The authorized representative in Indonesia is PT. ANDINI SARANA.

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
DENJOY i3 Gold Rotary File
Analysis ID: AKL 10603918365

Risk Classification

Kelas Resiko : A

Product Class

Kelas : 1

Country of Origin

China

Authorized Representative

PT. ANDINI SARANA

AR Address

Jln. Rawa Sumur III, Kav. III, Blok DD No. 11. Kawasan Industri Pulogadung Jakarta Timur

Registration Date

Dec 13, 2019

Expiry Date

Sep 15, 2024

Product Type

Surgical Dental Equipment

Dental hand instrument.

Non Electromedic Non Sterile

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