STARGEL10 DAT - Indonesia BPOM Medical Device Registration
STARGEL10 DAT is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20209220085. The device is manufactured by HAEMOKINESIS LIMITED from Australia, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is SAKEFA.
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
HAEMOKINESIS LIMITEDCountry of Origin
Australia
Authorized Representative
SAKEFAAR Address
Jl. Cireunde Raya No.26 Kel. Cireunde Kec. Ciputat Timur
Registration Date
Apr 28, 2022
Expiry Date
Jun 28, 2025
Product Type
Products used in the manufacture of blood preparations and preparations of origin and blood
Automated blood grouping and antibody test system.
Invitro Diagnostics
DAY LISS Diluent
DAY Neutral Gel
DAY Validation Control
DAY Anti-B (LB-2)
DAY Anti-D (DVI-) (TH-28)
DAY AHG Gel (Polyspecific anti-human globulin)
STARGEL10 3 Cell Screen
DAY Set Day Cells I-II-III
SET DAYcells A1, B
STARGEL10™ AHG
DAY AHG Gel (Polyspecific anti-human globulin)
HAEMOKINESIS LIMITED
INFITEK BR4-436 Blood Bank Refrigerator
INFITEK CO., LTD.
BMS Automatic Blood Separator
WUHAN BMS MEDICALTECH CO., LTD.
INFITEK Platelet Oscillating Incubator
INFITEK CO., LTD.
OXYPOWER Medical Oxygen Concentrator
JOINT-STOCK COMPANY
OXYPOWER Medical Oxygen Concentrator
JOINT-STOCK COMPANY
DEMOTEK Sterile Blood Bag Double
DEMOPHORIUS LTD.
DEMOTEK Transfer Bag 250ml
DEMOPHORIUS LTD
DEMOTEK Transfer Bag 1300ml
DEMOPHORIUS LTD
SARA INSTRUMENT
DIA.PRO DIAGNOSTIC BIOPROBES S.R.L