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.
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Risk Classification
Product Class
Kelas : 3
Manufacturer
APOLLO ENDOSURGERY COSTA RICA S.R.LCountry of Origin
Costa Rica
Authorized Representative
PT. PRO-HEALTH INTERNATIONALAR 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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