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OVERSTITCH SX™ Endoscopic Suturing System - Indonesia BPOM Medical Device Registration

OVERSTITCH SX™ Endoscopic Suturing System is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20801420450. The device is manufactured by APOLLO ENDOSURGERY, INC. from United States, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. PRO-HEALTH INTERNATIONAL.

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BPOM Registered
Risk Class Kelas Resiko : B
OVERSTITCH SX™ Endoscopic Suturing System
Analysis ID: AKL 20801420450

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Country of Origin

United States

Authorized Representative

PT. PRO-HEALTH INTERNATIONAL

AR Address

Komplek Perkantoran Duta Merlin Blok C 35-36, Jl. Gajah Mada 3-5 RT 002 RW 005, Prov. DKI Jakarta, Kota Jakarta Pusat, Kec. Gambir, Kel. Petojo Utara

Registration Date

Dec 30, 2024

Expiry Date

Sep 16, 2026

Product Type

Diagnostic Gastroenterology-Urology Equipment

Endoscope and accessories

Non Electromedic Sterile

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