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TOP FINE Insulin Pen Needle - Indonesia BPOM Medical Device Registration

TOP FINE Insulin Pen Needle is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20902712054. The device is manufactured by MEDEXEL CO., LTD. from Korea, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. SISTAR INDONESIA.

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 : B
TOP FINE Insulin Pen Needle
Analysis ID: AKL 20902712054

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Manufacturer

MEDEXEL CO., LTD.

Country of Origin

Korea

Authorized Representative

PT. SISTAR INDONESIA

AR Address

Jl. Setrasari Kulon I No. 3 Bandung 40152

Registration Date

Aug 24, 2020

Expiry Date

May 06, 2025

Product Type

Therapeutic General and Individual Hospital Equipment

Hypodermic single lumen needle.

Non Electromedic Sterile

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