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TORAY TR-8000 Single Patient Dialysis System - Indonesia BPOM Medical Device Registration

TORAY TR-8000 Single Patient Dialysis System is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20805913925. The device is manufactured by FENWAL CONTROLS OF JAPAN LTD, NAGANO PLANT from Japan, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is ABADINUSA USAHASEMESTA.

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
TORAY TR-8000 Single Patient Dialysis System
Analysis ID: AKL 20805913925

Risk Classification

Kelas Resiko : C

Product Class

Kelas : 2

Country of Origin

Japan

Authorized Representative

ABADINUSA USAHASEMESTA

AR Address

Jalan Raden Saleh No. 45 G

Registration Date

Sep 26, 2023

Expiry Date

Feb 05, 2028

Product Type

Therapeutic Gastroenterology-Urology Equipment

Hemodialysis system and accessories.

Non Radiation Electromedics

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