SULFOLYSER - Indonesia BPOM Medical Device Registration
SULFOLYSER is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20208917977. The device is manufactured by SYSMEX CORPORATION, ONO FACTORY. from Japan, 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
SYSMEX CORPORATION, ONO FACTORY.Country of Origin
Japan
Authorized Representative
PT. SYSMEX INDONESIAAR Address
Cyber 2 Tower, 5th Floor Unit E Jl. HR. Rasuna Said Blok X.5 No.13
Registration Date
Jan 07, 2025
Expiry Date
Dec 07, 2028
Product Type
Hematological Reagents
Red cell lysing reagent.
Invitro Diagnostics
POCH-PACK L PPL-200A
SYSMEX CELLSHEATH
POCH-PACK D PPD - 300A
STROMATOLYSER -FB
STROMATOLYSER-4DL
CELLPACK
SYSMEX Sulfolyser SLS
SYSMEX Stromatolyser™ -NR Lysing Reagen
STROMATOLYSER-WH
SYSMEX Lysercell ™ WNR
SYSMEX Automated Blood Coagulation Analyzer CN-6000
SYSMEX CORPORATION
XN CAL PF
DASH, INC.
POCH-PACK L PPL-200A
SYSMEX CORPORATION, ONO FACTORY.
XN-CHECK™ L3
DASH, INC.
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.