MINDRAY E3 Estriol (CLIA) - Indonesia BPOM Medical Device Registration
MINDRAY E3 Estriol (CLIA) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101918231. The device is manufactured by SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD. from China, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. MINDRAY MEDICAL 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
Country of Origin
China
Authorized Representative
PT. MINDRAY MEDICAL INDONESIAAR Address
Menara DEA II Lt.17, Jl. Mega Kuningan Barat Kav.E4.3 No.1-2, Kel. Kuningan Timur, Kec.Setiabudi Kawasan Mega Kuningan, Jakarta Selatan
Registration Date
Jul 25, 2024
Expiry Date
Aug 29, 2028
Product Type
Clinical Chemistry Test System
Estriol test system (kit & cair)
Invitro Diagnostics
MINDRAY C-reactive Protein (CRP) Kit (Latex Immunoturbidimetric Method)
MINDRAY M-53LH Lyse
MINDRAY Liver Fibrosis Multi Control (H)
MINDRAY Laminin (CLIA)
MINDRAY Prolactin (CLIA)
MINDRAY Estradiol Calibrators
MINDRAY LH Luteinizing Hormone(CLIA)
MINDRAY Estradiol (CLIA)
MINDRAY Hyaluronic acid (CLIA)
MINDRAY ADA Calibrator
MINDRAY ME7 Diagnostic Ultrasound System
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD
MINDRAY ASO/CRP/RF Triple Control
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD
MINDRAY Hypertension Multi Control (H)
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD
MINDRAY ALD Calibrators
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD
MINDRAY M-5LEO (II) LYSE
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.
MINDRAY Urine Sediment Control Level III
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD
MINDRAY M-5LEO (I) Bright
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD
MINDRAY LC LYSE
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD
MINDRAY Hypertension Multi Control (L)
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD
MINDRAY BS-230 Chemistry Analyzer and Accessories
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

