MINDRAY TDR ONE-64 - Indonesia BPOM Medical Device Registration
MINDRAY TDR ONE-64 is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20302220014. The device is manufactured by HUNAN MINDRAY MEDICAL TECHNOLOGY 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
Manufacturer
HUNAN MINDRAY MEDICAL TECHNOLOGY CO.,LTDCountry 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
Feb 17, 2022
Expiry Date
Mar 30, 2026
Product Type
Microbiology Equipment
Microorganism differentiation and identification device.
Invitro Diagnostics
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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
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