MINDRAY PCT Control (H) - Indonesia BPOM Medical Device Registration
MINDRAY PCT Control (H) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20303913628. 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 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
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
Jan 14, 2024
Expiry Date
Aug 29, 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
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MINDRAY Digital Radiography System
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MINDRAY sCD14-ST Control (L)
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MINDRAY TESTO II Testosterone (CLIA)
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MINDRAY HbA1c Hemoglobin A1c Kit (Enzymatic Assay Method) โ Twin Test
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MINDRAY ToRCH IgM Positive Control
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

