KEYA MEDICAL TECHNOLOGY CO.,LTD.

FDA Device Registration & Listing · Beijing, CN · Registration 3025430791

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3025430791
FEI Number
3025430791
Entity Name
KEYA MEDICAL TECHNOLOGY CO.,LTD.
City/State/Country
Beijing, CN
Establishment Address
No.1502, Floor 15, Building 1 , Yard No.1, Ronghua South Road, Beijing Economic-Technological Development Area, Beijing 100000, CN
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Keya Medical Technology Co.,Ltd. (Owner Number: 10086516)
Owner / Operator Contact Address
No.1502, Floor 15, Building 1 , Yard No.1, Ronghua South Road, Beijing Economic-Technological Development Area, Beijing, CN-BJ 100000, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
PMA Number
N/A

All Registered Proprietary Names

DEEPVESSEL Plaque DEEPVESSEL FFR

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
QIH Automated Radiological Image Processing Software Radiology Class 2 892.2050 2026-06-09
PJA Coronary Vascular Physiologic Simulation Software Cardiovascular Class 2 870.1415 2022-11-15

Official Correspondent

Yingguang Li

US Agent Details

Mary Waiss Business: KeyaMed NA Inc. Email: maryw@keyamedical.com Phone: (425) 4780433

Related Public Records

Same Entity

Keya Medical Technology Co.,Ltd.
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
K242270 Orthofix Srl OrthoNext Platform System 2024-12-19
K261713 FUJIFILM Healthcare Americas Corporation Synapse PACS (7.6.0) 2026-06-18
K243647 FUJIFILM Healthcare Americas Corporation Synapse PACS (7.5) 2025-06-30

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3025430791. Last updated year: 2026. Please use registration number 3025430791 when referencing this establishment in official correspondence.
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