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HD Hollow Fiber Hemodialyzer - Indonesia BPOM Medical Device Registration

HD Hollow Fiber Hemodialyzer is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20805321027. The device is manufactured by JIANGXI HONGDA MEDICAL EQUIPMENT GROUP LTD from China, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. MIRACHEN INACI.

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
HD Hollow Fiber Hemodialyzer
Analysis ID: AKL 20805321027

Risk Classification

Kelas Resiko : C

Product Class

Kelas : 2

Country of Origin

China

Authorized Representative

PT. MIRACHEN INACI

AR Address

Jl. Mayor Pol. Zainal Arifin No. 159A, RT.59, Kelurahan Sumber Rejo, Kecamatan Balikpapan Tengah, Kota Balikpapan, Prov. Kalimantan Timur

Registration Date

Nov 21, 2023

Expiry Date

May 10, 2028

Product Type

Therapeutic Gastroenterology-Urology Equipment

Hemodialysis system and accessories.

Non Electromedic Sterile

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