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Spatz3 Adjustable Balloon System - Indonesia BPOM Medical Device Registration

Spatz3 Adjustable Balloon System is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 30805320917. The device is manufactured by SPARROW FGIA, INC from Israel, and is classified as Risk Class Kelas Resiko : D. The authorized representative in Indonesia is PT. AIR THEN PHARMA.

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
Spatz3 Adjustable Balloon System
Analysis ID: AKL 30805320917

Risk Classification

Kelas Resiko : D

Product Class

Kelas : 3

Manufacturer

SPARROW FGIA, INC

Country of Origin

Israel

Authorized Representative

PT. AIR THEN PHARMA

AR Address

CITRA TOWER, NORTH TOWER LT 10 UNIT 10 A, JL. BENYAMIN SUAEB KAV. A6, KEMAYORAN, JAKARTA PUSAT 10630

Registration Date

Sep 21, 2023

Expiry Date

Jun 07, 2025

Product Type

Therapeutic Gastroenterology-Urology Equipment

Intragastric Balloon System

Non Electromedic Sterile

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