Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008252267

FEI Number

3008252267

Entity Name

Ningbo Runyes Medical Instrument Co., Ltd.

City/State/Country

Ningbo Zhejiang, CN

Establishment Address

No. 456 Tonghui Road, Jiangbei Investment & Pioneering Park C, Ningbo Zhejiang 315033, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Ningbo Runyes Medical Instrument Co., Ltd. (Owner Number: 10052869)

Owner / Operator Contact Address

No. 456 Tonghui road, Jiangbei Investment & Pioneering Park C, Ningbo, CN-NOTA 315033, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K231449

PMA Number

N/A

All Registered Proprietary Names

Diagnostic X-Ray Equipment POCT22 Runyes Dental Digital Imaging Sensor X-Ray Diagnostic Equipment RAY68 (W) X-Ray Diagnostic Equipment RAY68 (M) TeliCam Diagnostic X-Ray Equipment RAY88(P) Diagnostic X-Ray Equipment RAY98(P) Diagnostic X-Ray Equipment MobileX R98

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EHD	Unit, X-Ray, Extraoral With Timer	Dental	Class 2	872.1800	2026-02-04
MUH	System, X-Ray, Extraoral Source, Digital	Dental	Class 2	872.1800	2025-02-24
EHD	Unit, X-Ray, Extraoral With Timer	Dental	Class 2	872.1800	2016-10-13
QJK	Intraoral Camera	Dental	Class 2	872.3661	2024-06-04
EHD	Unit, X-Ray, Extraoral With Timer	Dental	Class 2	872.1800	2023-07-26

Official Correspondent

No official correspondent registered.

US Agent Details

Claude Berthoin Business: 510kfda, Inc Email: claude@510kfda.com Phone: (386) 8710908

Related Public Records

Same Entity

Ningbo Runyes Medical Instrument 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
K991310	Villa Sistemi Medicali S.P.A.	EXPLOR-X 70	1999-06-18
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

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.

Similar Registrations

Registration Number	Establishment Name	Location
3005581016	GUILIN WOODPECKER MEDICAL INSTRUMENT CO., LTD	GUILIN CITY Guangxi, CN
3007933232	DIGIMED CO., LTD	Seoul, KR
3003528079	XLINE SRL	ASSAGO Milano, IT
3002994636	DE GOTZEN S.R.L.	FAGNANO OLONA Varese, IT
3008770655	BEYES DENTAL INC	Toronto Ontario, CA

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008252267. Last updated year: 2026. Please use registration number 3008252267 when referencing this establishment in official correspondence.