YHLO iFlash-2019-nCoV Antigen - Indonesia BPOM Medical Device Registration
YHLO iFlash-2019-nCoV Antigen is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20303126464. The device is manufactured by SHENZHEN YHLO BIOTECH CO,,LTD from China, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is FAITHFUL MEDICAL GRACE.
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
SHENZHEN YHLO BIOTECH CO,,LTDCountry of Origin
China
Authorized Representative
FAITHFUL MEDICAL GRACEAR Address
Mitra Sunter Boulevard Blok B No.39 Jl. Yos Sudarso Kav. 89
Registration Date
Feb 14, 2022
Expiry Date
Feb 04, 2026
Product Type
Serological Reagents
Respiratory viral panel multiplex nucleic acid assay
Invitro Diagnostics
YHLO UNICELL-cTnI
YHLO UNICELL CK-MB
YHLO UNICELL-NT-proBNP
YHLO iFlash Toxo IgG (CLIA)
YHLO iFlash CMV IgG (CLIA)
YHLO iFlash Anti TP (Antibody To Treponema Pallidum) CLIA
YHLO UNICELL D-DIMER
YHLO iFlash Free PSA (CLIA)
YHLO iFlash CEA
YHLO iFlash CA 19-9
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