FRESENIUS Amicore Apheresis Kit - Single Needle - Indonesia BPOM Medical Device Registration
FRESENIUS Amicore Apheresis Kit - Single Needle is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20209719613. The device is manufactured by FENWAL INTERNATIONAL INC. from Dominican, and is classified as Risk Class Kelas Resiko : C. 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
FENWAL INTERNATIONAL INC.Country of Origin
Dominican
Authorized Representative
PT. FRESENIUS KABI INDONESIAAR Address
Menara Bidakara 1 Lt 19, Jl. Jend Gatot Subroto Kav 71-73
Registration Date
Jan 02, 2025
Expiry Date
Jan 09, 2028
Product Type
Products used in the manufacture of blood preparations and preparations of origin and blood
Empty container for the collection and processing of blood and blood components.
Non Electromedic Sterile
AMICORE Apheresis Kit - Single Needle with Two Platelet Containers
S5L Platelet Set (5-day storage) SN
P1YA White Blood Cell Set
PL1 Plasma Exchange Set
LOVO Med Cell Processing Disposables Kit with Bag Access
Transfer-Pack Container with Male Luer Adapter - 1000 mL
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.
AGILIA SP PCA WIFI ID
FRESENIUS VIAL
AMICORE Apheresis Kit - Single Needle with Two Platelet Containers
FENWAL INTERNATIONAL INC.
COMPOLAB TM Cuvette
EKF-DIAGNOSTIC GMBH
AmiCORE Apheresis System
FRESENIUS HEMOCARE GMBH