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INZONE® Detachment System - Indonesia BPOM Medical Device Registration

INZONE® Detachment System is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 31003127303. The device is manufactured by BENCHMARK ELECTRONICS, INC from United States, and is classified as Risk Class Kelas Resiko : D. The authorized representative in Indonesia is PT. WICAKSANA OVERSEAS INTERNATIONAL.

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 : D
INZONE® Detachment System
Analysis ID: AKL 31003127303

Risk Classification

Kelas Resiko : D

Product Class

Kelas : 3

Country of Origin

United States

Authorized Representative

PT. WICAKSANA OVERSEAS INTERNATIONAL

AR Address

Jl. Ancol Barat VII Blok A 5D No. 2 RT.006/RW.001, Kel. Ancol, Kec. Pademangan, Kota Adm. Jakarta Utara, Provinsi DKI Jakarta

Registration Date

Jul 25, 2023

Expiry Date

Jan 31, 2024

Product Type

Therapeutic Neurology Equipment

Neurovascular embolization device.

Non Radiation Electromedics

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