EZITELL Syphilis Rapid Test Cassette (Whole Blood/Serum/Plasma) - Indonesia BPOM Medical Device Registration
EZITELL Syphilis Rapid Test Cassette (Whole Blood/Serum/Plasma) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20303321219. The device is manufactured by HANGZHOU ALLTEST BIOTECH CO., LTD. from China, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is ANDAMAN 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
HANGZHOU ALLTEST BIOTECH CO., LTD.Country of Origin
China
Authorized Representative
ANDAMAN MEDICAL INDONESIAAR Address
Menara Cardig Lantai 1, Jalan Raya Halim Perdanakusuma
Registration Date
Jun 21, 2023
Expiry Date
Mar 14, 2028
Product Type
Serological Reagents
Treponema pallidum treponemal test reagents.
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