dBEST One Step Rapid Test LH Ovulation Strip Test - Indonesia BPOM Medical Device Registration
dBEST One Step Rapid Test LH Ovulation Strip Test is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101917978. The device is manufactured by AMERITEK, INC. from United States, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. 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
AMERITEK, INC.Country of Origin
United States
Authorized Representative
PT. FAITHFUL MEDICAL GRACEAR Address
Mitra Sunter Boulevard Blok B No.39 Jl. Yos Sudarso Kav. 89
Registration Date
Nov 29, 2019
Expiry Date
Aug 10, 2024
Product Type
Clinical Chemistry Test System
Luteinizing hormone test system (strip & midstream)
Invitro Diagnostics
SM MALB Reagent Kit
URIT MEDICAL ELECTRONIC CO., LTD
SM Multi Control for Clinical Chemistry Analyzer Level 1
URIT MEDICAL ELECTRONIC CO., LTD
SM TB-DCA Reagent Kit
URIT MEDICAL ELECTRONIC CO., LTD
SM DB-DCA Reagent Kit
URIT MEDICAL ELECTRONIC CO., LTD
SM – 700 Automatic Chemistry Analyzer
URIT MEDICAL ELECTRONIC CO., LTD
SM FC-73 Flow Cytometer and Accessories
URIT MEDICAL ELECTRONIC CO., LTD
SM Control Hematology Analyzer for 3 Diff
URIT MEDICAL ELECTRONIC CO., LTD
SM Control Hematology Analyzer for 5 Diff
URIT MEDICAL ELECTRONIC CO., LTD
SM Control Hematology Analyzer for 5 Diff (Normal Level)
URIT MEDICAL ELECTRONIC CO., LTD
SM 420 Automatic Chemistry Analyzer and Accessories
URIT MEDICAL ELECTRONIC CO., LTD