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ONE TRUE FIT Condom - Indonesia BPOM Medical Device Registration

ONE TRUE FIT Condom is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 21104021531. The device is manufactured by KAREX INDUSTRIES SDN. BHD from Malaysia, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. MODERN TIMELESS ESSENTIALS.

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 : C
ONE TRUE FIT Condom
Analysis ID: AKL 21104021531

Risk Classification

Kelas Resiko : C

Product Class

Kelas : 2

Country of Origin

Malaysia

Authorized Representative

PT. MODERN TIMELESS ESSENTIALS

AR Address

Jl.Sutera Niaga I No.7, RT.3/RW.3

Registration Date

Jun 03, 2024

Expiry Date

Apr 24, 2029

Product Type

Therapeutic Obstetric and Gynecological Equipment

Condom.

Non Electromedic Non Sterile

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