INNODX PCT CMIA - Indonesia BPOM Medical Device Registration
INNODX PCT CMIA is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20303420013. The device is manufactured by XIAMEN INNODX BIOTECH CO., LTD. from China, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. SUMIFIN CITRA ABADI.
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
XIAMEN INNODX BIOTECH CO., LTD.Country of Origin
China
Authorized Representative
PT. SUMIFIN CITRA ABADIAR Address
Jl. Alam Sutera Boulevard Alam Sutera Town Center (ASTC) Blok 10D No.19, Kel. Pakulonan, Kec. Serpong Utara - Tangerang Selatan 15325
Registration Date
Jan 14, 2024
Expiry Date
Feb 21, 2028
Product Type
Serological Reagents
Device to detect and measure non-microbial analyte(s) in human clinical specimens to aid in assessment of patients with suspected sepsis
Invitro Diagnostics
INNODX TSH CMIA
INNODX CK-MB CMIA
INNODX TT3 CMIA
INNODX DU Diluent Universal
INNODX TSH II CMIA
INNODX 25-OH-VD CMIA
INNODX TT4 CMIA
INNODX CA125 CMIA
INNODX FT3 CMIA
INNODX FT4 CMIA
DIAFIN DFRC-24A Refrigerated Centrifuge
CHANGSHA YINGTAI INSTRUMENT CO. LTD.,
DIAFIN DFLC-22 Low Speed Centrifuge
CHANGSHA YINGTAI INSTRUMENT CO. LTD.,
DIAFIN DFLC-30 Clinical Centrifuge
CHANGSHA YINGTAI INSTRUMENT CO. LTD.,
ZENIX Glycated Hemoglobin Test kit (HPLC)
SHENZHEN XILAIHENG MEDICAL ELECTRONICS CO., LTD.
DIAFIN DFRC-12A Refrigerated Centrifuge
CHANGSHA YINGTAI INSTRUMENT CO. LTD.,
DIAFIN DFRC-12B Refrigerated Centrifuge and Accessories
CHANGSHA YINGTAI INSTRUMENT CO. LTD.,
INNODX TSH CMIA
XIAMEN INNODX BIOTECH CO., LTD.
ZELL-ESR Erythrocyte Sedimentation Rate Analyzer
STERILE SAFEQUIP AND CHEMICALS LLP
KEWEI RV-IgM Test Kit
BEIJING KEWEI CLINICAL DIAGNOSTIC REAGENT INC
DIAFIN DFGC-23 Blood Gel Cards Centrifuge
CHANGSHA YINGTAI INSTRUMENT CO. LTD.,