Pure Global

THERANOVA - Indonesia BPOM Medical Device Registration

THERANOVA is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20805028233. The device is manufactured by GAMBRO DIALYZER GMBH from Germany, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. TAWADA HEALTHCARE.

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 : C
THERANOVA
Analysis ID: AKL 20805028233

Risk Classification

Kelas Resiko : C

Product Class

Kelas : 2

Country of Origin

Germany

Authorized Representative

PT. TAWADA HEALTHCARE

AR Address

Rukan Permata Senayan Blok A18-19 Lantai 5 Jl. Tentara Pelajar No. 5

Registration Date

Jun 25, 2024

Expiry Date

Dec 31, 2025

Product Type

Therapeutic Gastroenterology-Urology Equipment

High permeability hemodialysis system.

Non Electromedic Sterile

Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing