AyoTes HbA1c Reagent Kit (HPLC) - Indonesia BPOM Medical Device Registration
AyoTes HbA1c Reagent Kit (HPLC) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20207320221. The device is manufactured by SHENZHEN LIFOTRONIC TECHNOLOGY CO., LTD from China, and is classified as Risk Class Kelas Resiko : B. 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
SHENZHEN LIFOTRONIC TECHNOLOGY CO., LTDCountry of Origin
China
Authorized Representative
PT. HEALTHY FAMILY FOCUSAR Address
Komplek Delta Building Blok B 1-2, Jalan Suryopranoto No. 1-9
Registration Date
Feb 07, 2023
Expiry Date
Feb 01, 2026
Product Type
Haematology Package and Kit
Glycosylated hemoglobin assay.
Invitro Diagnostics
BIOSET ECL 8000 Automatic ECLIA Immunoassay Analyzer
LIFOTRONIC Thyroglobulin Antibody (Electrochemiluminescence Immunoassay)
LIFOTRONIC Shock Wave Therapy System
BOSKA Temperature Management System
LIFOTRONIC Wound Clean System
LIFOTRONIC Wound Clean System
LIFOTRONIC Alpha-Fetoprotein (eCLlA)
LIFOTRONIC D-Dimer STAT (eCLIA)
Lifotronic Wound Clean System
LIFOTRONIC Vitamin B12 (eCLIA)
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.