HEMY® Hollow Fiber Dialyzer - Indonesia BPOM Medical Device Registration
HEMY® Hollow Fiber Dialyzer is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20805026182. The device is manufactured by BAIN MEDICAL EQUIPMENT (GUANGZHOU) CO., LTD. from China, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. SURGIKA ALKESINDO.
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.
Risk Classification
Product Class
Kelas : 2
Manufacturer
BAIN MEDICAL EQUIPMENT (GUANGZHOU) CO., LTD.Country of Origin
China
Authorized Representative
PT. SURGIKA ALKESINDOAR Address
Jl. Letjen Suprapto No.60, Gedung Indra Sentral unit G-H, Cempaka Putih
Registration Date
Mar 24, 2022
Expiry Date
Feb 17, 2024
Product Type
Therapeutic Gastroenterology-Urology Equipment
Hemodialysis system and accessories.
Non Electromedic Non Sterile
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