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HELIXONE Dialyser - Indonesia BPOM Medical Device Registration

HELIXONE Dialyser is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20805612122. The device is manufactured by FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH from Germany, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is FRESENIUS MEDICAL CARE INDONESIA.

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
HELIXONE Dialyser
Analysis ID: AKL 20805612122

Risk Classification

Kelas Resiko : C

Product Class

Kelas : 2

Country of Origin

Germany

Authorized Representative

FRESENIUS MEDICAL CARE INDONESIA

AR Address

Tempo Scan Tower, Lt. 20, Jl. H.R. Rasuna Said Kav. 3-4

Registration Date

Feb 01, 2025

Expiry Date

Sep 17, 2029

Product Type

Therapeutic Gastroenterology-Urology Equipment

Hemodialysis system and accessories.

Non Electromedic Non Sterile

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