OverStitch NXT™ Endoscopic Suturing System - Indonesia BPOM Medical Device Registration

OverStitch NXT™ Endoscopic Suturing System is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20801520014. The device is manufactured by VIANT MEDICAL, INC. from United States, 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

OverStitch NXT™ Endoscopic Suturing System

Analysis ID: AKL 20801520014

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Manufacturer

VIANT MEDICAL, INC.

Country of Origin

United States

Authorized Representative

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

Jan 14, 2025

Expiry Date

Sep 16, 2026

Product Type

Diagnostic Gastroenterology-Urology Equipment

Endoscope and accessories

Non Electromedic Sterile

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MedTech Regulatory Expert

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