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ZSI Malleable Penile Implant - Indonesia BPOM Medical Device Registration

ZSI Malleable Penile Implant is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20803126547. The device is manufactured by ZTC TECHNOLOGY from Switzerland, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. EDISON AMBASSADOR MEANS.

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
ZSI Malleable Penile Implant
Analysis ID: AKL 20803126547

Risk Classification

Kelas Resiko : C

Product Class

Kelas : 2

Manufacturer

ZTC TECHNOLOGY

Country of Origin

Switzerland

Authorized Representative

PT. EDISON AMBASSADOR MEANS

AR Address

Jl. Oasis Sememi Raya No. 1 RT 01 RW 04

Registration Date

Nov 01, 2021

Expiry Date

May 27, 2025

Product Type

Prosthetic Gastroenterology-Urology Equipment

Penile rigidity implant.

Non Electromedic Sterile

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