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 20208420306. 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
Oct 14, 2024
Expiry Date
May 13, 2029
Product Type
Hematological Reagents
Calibrator for red cell and white cell counting.
Invitro Diagnostics
ClearLLab Control Cells Normal
ClearLLab Control Cells Abnormal
XN CAL PF
XN-CHECK L2
EIGHTCHECK-3WP-H
XN-CHECK™ L3
Eightcheck-3WP-L
EIGHTCHECK-3WP-L
EIGHTCHECK-3WP-H
XN CHECK L1
EIGHTCHECK-3WP-L
DASH, INC.
EIGHTCHECK-3WP-H
DASH, INC.
XN CHECK L1
DASH, INC.
XN CHECK L3
DASH, INC.
XN-L CHECK L2
DASH, INC.
XN CHECK BF L2
DASH, INC.
XN CHECK BF L1
DASH, INC.
XN-L CHECK L3
DASH, INC.
XN CHECK L2
DASH, INC.
SCS-1000
DASH, INC.