# RADISEN CO LTD

FEI: 3017004860
Status: Active
Establishment types: Manufacture Medical Device; Complaint File Establishment per 21 CFR 820.198
Owner/operator: Radisen Co Ltd (#10079944)

Address: B-602, Hifield Building, 66, Beolmal-ro, Dongan-gu, Anyang Gyeonggi, 14058, KR

Mandatory US Agent: Mtech Group LLC

## Products

Total registered: 1
Top product codes: MQB
Regulation §: 892.1680

Proprietary names: PEDRA-1417MG Digital Flat Panel X-ray Detector, PEDRA-1417MC Digital Flat Panel X-ray Detector

## Source

- openFDA: https://api.fda.gov/device/registrationlisting.json?search=registration.fei_number:%223017004860%22
- FDA Registration Lookup: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm?lid=3017004860