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AK 98 Dialysis Machine - Indonesia BPOM Medical Device Registration

AK 98 Dialysis Machine is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20805026578. The device is manufactured by GAMBRO DASCO S.P.A from Italy, 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
AK 98 Dialysis Machine
Analysis ID: AKL 20805026578

Risk Classification

Kelas Resiko : C

Product Class

Kelas : 2

Manufacturer

GAMBRO DASCO S.P.A

Country of Origin

Italy

Authorized Representative

PT. TAWADA HEALTHCARE

AR Address

Rukan Permata Senayan Blok A18-19 Lantai 1-2 Jl. Tentara Pelajar No. 5

Registration Date

Jan 10, 2024

Expiry Date

Dec 31, 2025

Product Type

Therapeutic Gastroenterology-Urology Equipment

Hemodialysis system and accessories.

Non Radiation Electromedics

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