XN-CHECK™ L3 - Indonesia BPOM Medical Device Registration
XN-CHECK™ L3 is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20208125685. 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.
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
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
Dec 23, 2024
Expiry Date
Jan 16, 2028
Product Type
Hematological Reagents
Hematology quality control mixture.
Invitro Diagnostics
ClearLLab Control Cells Normal
ClearLLab Control Cells Abnormal
XN CAL PF
XN-CHECK L2
EIGHTCHECK-3WP-H
Eightcheck-3WP-L
EIGHTCHECK-3WP-L
EIGHTCHECK-3WP-H
XN CHECK L1
XN-L CHECK L2
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.
SYSMEX CD4% easy count kit
EXBIO PRAHA, A.S.
SYSMEX Ca Cal S
SYSMEX CORPORATION, SEISHIN FACTORY.
JEOL CA-21391 RAMINI RACK HANDLER
JEOL YAMAGATA CO., LTD.