AMICORE Apheresis System - Indonesia BPOM Medical Device Registration
AMICORE Apheresis System is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20209912328. The device is manufactured by PLEXUS MANUFACTURING SDN BHD. from Malaysia, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. FRESENIUS KABI 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.
Risk Classification
Product Class
Kelas : 2
Manufacturer
PLEXUS MANUFACTURING SDN BHD.Country of Origin
Malaysia
Authorized Representative
PT. FRESENIUS KABI INDONESIAAR Address
Menara Bidakara 1 Lt.19, Jl. Gatot Subroto Kav 71 - 73 Menteng Dalam, Tebet, Jakarta Selatan 12870
Registration Date
Oct 25, 2023
Expiry Date
Jan 19, 2028
Product Type
Products used in the manufacture of blood preparations and preparations of origin and blood
Automated blood cell separator.
Invitro Diagnostics
CONOX Pediatric Sensor
FRESENIUS KABI (NANCHANG) CO., LTD.
FRESENIUS KABI 3 Way Stopcock
FRESENIUS KABI (NANCHANG) CO., LTD.
FRESENIUS 3-Way-Stopcock
CLINICO MEDICAL SP. Z.O.O.
AMICUS Separator and Accessories
FRESENIUS KABI WARRENDALE.
VS 10 DEHP-Free
CLINICO MEDICAL SP. Z O.O.
AmiCORE Apheresis Kit - Single Needle with Two Platelet Containers and PAS Connector
FENWAL INTERNATIONAL, INC.
FRESENIUS Amicore Apheresis Kit - Single Needle
FENWAL INTERNATIONAL INC.
AMICORE Apheresis Kit - Single Needle with Two Platelet Containers
FENWAL INTERNATIONAL INC.
AGILIA SP PCA WIFI ID
FRESENIUS VIAL
COMPOLAB TM Cuvette
EKF-DIAGNOSTIC GMBH