OverTube™ Endoscopic Access System - Indonesia BPOM Medical Device Registration

OverTube™ Endoscopic Access System is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20801126711. The device is manufactured by APOLLO ENDOSURGERY COSTA RICA S.R.L from Costa Rica, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PRO-HEALTH INTERNATIONAL.

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BPOM Registered

Risk Class Kelas Resiko : B

OverTube™ Endoscopic Access System

Analysis ID: AKL 20801126711

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Manufacturer

APOLLO ENDOSURGERY COSTA RICA S.R.L

Country of Origin

Costa Rica

Authorized Representative

PRO-HEALTH INTERNATIONAL

AR Address

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

Registration Date

Nov 08, 2021

Expiry Date

Dec 21, 2025

Product Type

Diagnostic Gastroenterology-Urology Equipment

Endoscope and accessories

Non Electromedic Non Sterile

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