Pure Global

INDIGO Aspiration System - Indonesia BPOM Medical Device Registration

INDIGO Aspiration System is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20505916233. The device is manufactured by PENUMBRA INC. from United States, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. BISAWI GROWS IN HARMONY.

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.

Free Database
Powered by Pure Global AI
BPOM Registered
Risk Class Kelas Resiko : C
INDIGO Aspiration System
Analysis ID: AKL 20505916233

Risk Classification

Kelas Resiko : C

Product Class

Kelas : 2

Manufacturer

PENUMBRA INC.

Country of Origin

United States

Authorized Representative

PT. BISAWI GROWS IN HARMONY

AR Address

Graha Kencana Blok EU Jl. Raya Perjuangan No.88 Kebun Jeruk Jakarta Barat

Registration Date

Sep 10, 2024

Expiry Date

Dec 31, 2026

Product Type

Therapeutic Cardiology Equipment

Embolectomy catheter.

Non Electromedic Non Sterile

Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing