STARGEL10 Newborn - Indonesia BPOM Medical Device Registration
STARGEL10 Newborn is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20209912227. The device is manufactured by HAEMOKINESIS LIMITED from Australia, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. SAKEFA.
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Risk Classification
Product Class
Kelas : 2
Manufacturer
HAEMOKINESIS LIMITEDCountry of Origin
Australia
Authorized Representative
PT. SAKEFAAR Address
Jalan Tarumanegara No.8
Registration Date
Aug 05, 2024
Expiry Date
Jan 08, 2029
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
STATUS1 STAT GROUP CHECK
YINGTAI Low Speed Centrifuge
CHANGSA YINGTAI INSTRUMENT CO.LTD.
YINGTAI DL8M Large Capacity Refrigerated Centrifuge
CHANGSHA YINGTAI INSTRUMENT CO.,LTD
DAY LISS Diluent
HAEMOKINESIS LIMITED
DAY Validation Control
HAEMOKINESIS LIMITED
DAY Neutral Gel
HAEMOKINESIS LIMITED
DAY Anti-B (LB-2)
HAEMOKINESIS LIMITED
DAY Anti-D (DVI-) (TH-28)
HAEMOKINESIS LIMITED
STARGEL10 3 Cell Screen
HAEMOKINESIS LIMITED
SET DAYcells A1, B
HAEMOKINESIS LIMITED
DAY Set Day Cells I-II-III
HAEMOKINESIS LIMITED