Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013779985

FEI Number

3013779985

Entity Name

REMEDI INC.

City/State/Country

Chuncheon Gangwon, KR

Establishment Address

2F, 69-14, Sakju-ro 145beon-gil, Chuncheon Gangwon 24232, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Remedi Inc. (Owner Number: 10060424)

Owner / Operator Contact Address

2F, 69-14, Sakju-Ro 145beon-Gil, Chuncheon, KR-42 072NN, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K240759

PMA Number

N/A

All Registered Proprietary Names

R-Sensor T-100 REMEX-T100 MobileX T-100 REMEX KA6 ES70 REMEX Xcam6 REMEX-GR100

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MUH	System, X-Ray, Extraoral Source, Digital	Dental	Class 2	872.1800	2020-10-10
EHD	Unit, X-Ray, Extraoral With Timer	Dental	Class 2	872.1800	2019-05-09
IZL	System, X-Ray, Mobile	Radiology	Class 2	892.1720	2021-09-13
IZL	System, X-Ray, Mobile	Radiology	Class 2	892.1720	2026-01-08
EHD	Unit, X-Ray, Extraoral With Timer	Dental	Class 2	872.1800	2025-05-07

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: David.Lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

Remedi Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K221008	Shanghai Handy Medical Equipment Co., Ltd.	HDR Sensor- HDR361 (Size 1), HDR Sensor- HDR461 (Size 2)	2022-06-22
K160788	Ray Co., Ltd.	RIOScan (RPS500)	2016-04-15
K991310	Villa Sistemi Medicali S.P.A.	EXPLOR-X 70	1999-06-18
K153059	Minxray, Inc.	HF1202H PowerPlus Portable X-ray Equipment	2016-02-02

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0009-2015	Gendex Corp	2	eXpertDC intraoral x-ray, models: eXpert DC, NA, 75 Inch reach; eXpert DC, NA, 65 Inch reach; eXpert DC, CN, 55 Inch reach; eXpert DC, WW, 75 Inch reach; eXpert DC, WW, 65 Inch reach; eXpert DC, WW, 55 Inch reach; OEM Arm Assembly w/o cables; Assy, Articulated Arm & Tubehead, eDC; and Assy, Articulated Arm & Tubehead, 765DC Product Usage: intraoral x-ray
Z-0016-2017	Panoramic Rental Corp.	2	Panoramic X-ray Model PC-1000, Laser-1000 packed in a crate Product Usage: The PC-1000 will enable the user to take panoramic x-ray images. The PC-1000/Laser1000 will enable the user to take panoramic x-ray images as well as cephalometric x-ray images.
Z-1470-2023	FUJIFILM Healthcare Americas Corporation	2	FujiFilm FDR AQRO (Model DR-XD1000)- A digital mobile X-ray system intended for use in general purpose radiography for generating radiographic images of human anatomy, including adult, pediatric, and neonatal exams
Z-3158-2024	FUJIFILM Healthcare Americas Corporation	2	The device is a mobile x-ray system designed to work with Fujifilm's GOS and CsI scintillator FDR D-EVO2 (DR-ID) 12XXSE) family of digital x-ray detectors coupled.

Similar Registrations

Registration Number	Establishment Name	Location
3042046320	QPIX SOLUTIONS, INC.	Morrisville, NC, US
3020117925	ATHLOS OY	Espoo Uusimaa, FI
2032641	CYBER MEDICAL IMAGING, INC.	Los Angeles, CA, US
3004706313	VATECH CO., LTD.	Hwaseong-si Gyeonggi, KR
3010281549	J. MORITA MFG. CORP., TOTTORI FACTORY	Kurayoshi Tottori, JP

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013779985. Last updated year: 2026. Please use registration number 3013779985 when referencing this establishment in official correspondence.