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ORBERA365™ Intragastric Balloon System - Indonesia BPOM Medical Device Registration

ORBERA365™ Intragastric Balloon System is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 30805220011. The device is manufactured by APOLLO ENDOSURGERY COSTA RICA S.R.L from Costa Rica, and is classified as Risk Class Kelas Resiko : D. The authorized representative in Indonesia is PT. PRO-HEALTH 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
ORBERA365™ Intragastric Balloon System
Analysis ID: AKL 30805220011

Risk Classification

Kelas Resiko : D

Product Class

Kelas : 3

Country of Origin

Costa Rica

Authorized Representative

PT. PRO-HEALTH INTERNATIONAL

AR Address

Komplek Perkantoran Duta Merlin Blok C 35-36 Jalan Gajah Mada 3-5

Registration Date

Jan 18, 2022

Expiry Date

Jul 22, 2025

Product Type

Therapeutic Gastroenterology-Urology Equipment

Intragastric Balloon System

Non Electromedic Non Sterile

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