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U9000 Plus Ultrafilter - Indonesia BPOM Medical Device Registration

U9000 Plus Ultrafilter is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20805124927. 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.

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BPOM Registered
Risk Class Kelas Resiko : C
U9000 Plus Ultrafilter
Analysis ID: AKL 20805124927

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 24, 2024

Expiry Date

Dec 31, 2025

Product Type

Therapeutic Gastroenterology-Urology Equipment

Water purification system for hemodialysis.

Non Electromedic Non Sterile

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