Eightcheck-3WP-L - Indonesia BPOM Medical Device Registration
Eightcheck-3WP-L is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20208125686. 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 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
SYSMEX INDONESIAAR Address
Cyber 2 Tower, 5th Floor Unit E Jl. HR. Rasuna Said Blok X.5 No.13
Registration Date
Dec 04, 2024
Expiry Date
Jan 16, 2028
Product Type
Hematological Reagents
Hematology quality control mixture.
Invitro Diagnostics
ClearLLab Control Cells Abnormal
ClearLLab Control Cells Normal
XN CAL PF
XN-CHECKโข L3
EIGHTCHECK-3WP-H
XN-CHECK L2
EIGHTCHECK-3WP-L
EIGHTCHECK-3WP-H
XN CHECK L1
XN-L CHECK L2
HISCL Troponin T hs Assay Kit
SYSMEX CORPORATION, SEISHIN FACTORY.
POCH-PACK D PPD - 300A
SYSMEX CORPORATION, ONO FACTORY.
STROMATOLYSER -FB
SYSMEX CORPORATION, ONO FACTORY.
STROMATOLYSER-4DL
SYSMEX CORPORATION, ONO FACTORY.
CELLPACK
SYSMEX CORPORATION, ONO FACTORY.
SYSMEX CELLPACK โข DFL
SYSMEX ASIA PACIFIC PTE., LTD.
HISCL HBeAg Assay Kit
JAPAN LYOPHILIZATION LABORATORY.
TruLab Urine Level 2
DIASYS DIAGNOSTIC SYSTEMS GMBH
TruLab Urine Level 1
DIASYS DIAGNOSTIC SYSTEMS GMBH
CELLPACK โข DCL
SYSMEX ASIA PACIFIC PTE., LTD.

