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FLEXI-SEAL SIGNAL Fecal Management System - Indonesia BPOM Medical Device Registration

FLEXI-SEAL SIGNAL Fecal Management System is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20805025345. The device is manufactured by FORTUNE MEDICAL INSTRUMENT CORP. from Taiwan (China), and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. PHARMINDO LESTARI AWARD.

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
FLEXI-SEAL SIGNAL Fecal Management System
Analysis ID: AKL 20805025345

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Country of Origin

Taiwan (China)

Authorized Representative

PT. PHARMINDO LESTARI AWARD

AR Address

Jl. Boulevard BGR No. 1, Komplek Pergudangan BGR Gudang M, Kel. Kelapa Gading Barat, Kec. Kelapa Gading, Jakarta Utara, DKI Jakarta

Registration Date

Sep 15, 2020

Expiry Date

Jun 22, 2025

Product Type

Therapeutic Gastroenterology-Urology Equipment

Colonic irrigation system.

Non Electromedic Non Sterile

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