XN CAL - Indonesia BPOM Medical Device Registration
XN CAL is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20208210936. The device is manufactured by DASH INC. from United States, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. SYSMEX INDONESIA.
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Risk Classification
Product Class
Kelas : 2
Manufacturer
DASH INC.Country of Origin
United States
Authorized Representative
PT. SYSMEX INDONESIAAR Address
Cyber 2 Tower, 5th Floor Unit E Jl. HR. Rasuna Said Blok X.5 No.13
Registration Date
Jul 19, 2021
Expiry Date
Jan 28, 2026
Product Type
Hematological Reagents
Calibrator for red cell and white cell counting.
Invitro Diagnostics
iQ Body Fluids Controls-Level I and Level II
Platelet Check L1
XN-L CHECK ™ L1
WRP Check EX
ADVIA 120/ADVIA 2120/ADVIA 2120i 3in1 TESTpoint™ Hematology Controls.
ADVIA 120/ADVIA 2120/ADVIA 2120i 3in1 TESTpoint Hematology Abnormal High Controls
XN CHECK™ L1
EIGHTCHECK - 3WP-N
SYSMEX SCS™ -1000
XN CAL™ PF
SYSMEX Automated Blood Coagulation Analyzer CN-6000
SYSMEX CORPORATION
XN CAL PF
DASH, INC.
SULFOLYSER
SYSMEX CORPORATION, ONO FACTORY.
POCH-PACK L PPL-200A
SYSMEX CORPORATION, ONO FACTORY.
EIGHTCHECK-3WP-H
DASH, INC.
XN-CHECK L2
DASH, INC.
SYSMEX CELLSHEATH
SYSMEX CORPORATION, ONO FACTORY.
XN-CHECK™ L3
DASH, INC.
SYSMEX CD4% easy count kit
EXBIO PRAHA, A.S.
SYSMEX Ca Cal S
SYSMEX CORPORATION, SEISHIN FACTORY.