MEDGYN Fetal Monitor - Indonesia BPOM Medical Device Registration
MEDGYN Fetal Monitor is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 21101916898. The device is manufactured by MEDGYN PRODUCTS INC. from United States, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. GLOBAL SYSTECH MEDIKA.
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
MEDGYN PRODUCTS INC.Country of Origin
United States
Authorized Representative
PT. GLOBAL SYSTECH MEDIKAAR Address
Jl. TB Simatupang No.17 RT.011/002 Kel. Susukan, Kec. Ciracas Jakarta Timur
Registration Date
Jun 11, 2024
Expiry Date
Apr 27, 2028
Product Type
Obstetric and Gynecological Monitoring Equipment
Fetal cardiac monitor.
Non Radiation Electromedics
MEDGYN Thermal Ablation System
MEDGYN Digital Video Colposcope
MEDGYN Digital Colposcope
MEDGYN Cryo Surgical Unit MGC - 200
MEDGYN Ultrasonic Pocket Doppler
MEDGYN Silicone Pessaries with Support
MEDGYN Ultrasonic Table Top Doppler
MEDGYN Fetal Monitor
MEDGYN Fetal Monitor
MEDGYN Cryotherapy
TOSAN Neonatal Resuscitator System
TOSAN CO.
KAVANDISH MATIN Electrosurgical System
KAVANDISH SYSTEM
KAVANDISH MEG1-E Electrosurgical Unit
KAVANDISH SYSTEM
KAVANDISH MATIN Electrosurgical Generator
KAVANDISH SYSTEM
AXION Defibrillator Monitor
AXION JSC.
AXION Electrocardiograph
AXION CONCERN JSC.
HUNAN BEYOND Infusion Pump
HUNAN BEYOND MEDICAL TECHNOLOGY CO., LTD.
ELETTRONICA Shortwave Therapy Unit
ELETTRONICA PAGANI S.R.L.
PAGANI Thermotherapy And Cryotherapy Combined
ELETTRONICA PAGANI S.R.L.
HUNAN BEYOND Syringe Pump
HUNAN BEYOND MEDICAL TECHNOLOGY CO., LTD.