AyoTes Dengue IgG/IgM Rapid Test Kit (Whole Blood/Plasma/Serum) - Indonesia BPOM Medical Device Registration
AyoTes Dengue IgG/IgM Rapid Test Kit (Whole Blood/Plasma/Serum) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20303420410. The device is manufactured by ASSURE TECH. (HANGZHOU) CO., LTD. from China, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. HEALTHY FAMILY FOCUS.
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
ASSURE TECH. (HANGZHOU) CO., LTD.Country of Origin
China
Authorized Representative
PT. HEALTHY FAMILY FOCUSAR Address
Komplek Delta Building Blok B 1-2, Jalan Suryopranoto No. 1-9
Registration Date
Aug 30, 2024
Expiry Date
Aug 29, 2027
Product Type
Serological Reagents
Dengue virus serological reagents
Invitro Diagnostics
Acuteck Hemoglobin Meter
DrAccu Testosterone FIA
DrAccu LH FIA
DrAccu Anti-Mullerian Hormone FIA
AyoTes HbsAg Rapid Test (Whole Blood/Serum/Plasma)
AyoTes Gonorrhea Rapid Test (Swab)
AyoTes Chlamydia Rapid Test (Secretion)
AyoTes Methamphetamine (MET) Rapid Test (Urine)
AyoTes Tetrahydrocannabinol (THC) Rapid Test (Urine)
AyoTes Multi Drug 7 Panel Test (AMP/THC/MOP/MET/BZO/COC/SOMA) (Urine)
AYOTES CLIA based Soluble Growth Stimulation Expressed Gene 2 Test Kit
BEIJING HOTGEN BIOTECH CO., LTD.
AYOTES CLIA based Pepsinogen I (PGI) Test Kit
BEIJING HOTGEN BIOTECH CO., LTD.
AYOTES CLIA based ฮฑ - Fetoprotein Test Kit
BEIJING HOTGEN BIOTECH CO., LTD.
AYOTES CLIA based Cytokeratin 19 Fragments Test Kit
BEIJING HOTGEN BIOTECH CO., LTD.
AyoTes CLIA based Aldosteron Test Kit
BEIJING HOTGEN BIOTECH CO., LTD.
AyoTes CLIA based Cortisol Test Kit
BEIJING HOTGEN BIOTECH CO., LTD.
AyoTes CLIA based 25-hydroxy-vitamin D (25-OH VD) Test Kit
BEIJING HOTGEN BIOTECH CO., LTD.
AyoTes CLIA based Testosterone Test Kit
BEIJING HOTGEN BIOTECH CO., LTD.
AyoTes CLIA based Myoglobin (MYO) Test Kit
BEIJING HOTGEN BIOTECH CO., LTD.
AYOTES CLIA Based Creatine Kinase MB (CK-MB) Test Kit
BEIJING HOTGEN BIOTECH CO., LTD.