Pure Global

NEWTON Urodynamic System - Indonesia BPOM Medical Device Registration

NEWTON Urodynamic System is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20801220425. The device is manufactured by TIC MEDIZINTECHNIK GMBH & CO. KG from Germany, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PARAMA TRIPTA MERCURY.

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.

Free Database
Powered by Pure Global AI
BPOM Registered
Risk Class Kelas Resiko : B
NEWTON Urodynamic System
Analysis ID: AKL 20801220425

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Country of Origin

Germany

Authorized Representative

PARAMA TRIPTA MERCURY

AR Address

Jalan Terusan Prof. Dr. Ir. Sutami kavling 3, Desa/Kelurahan Sarijadi, Kec.Sukasari, Kota Bandung, Provinsi Jawa Barat, Kode Pos: 40151

Registration Date

Nov 03, 2022

Expiry Date

Dec 31, 2026

Product Type

Diagnostic Gastroenterology-Urology Equipment

Urodynamics measurement system.

Non Radiation Electromedics

Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing