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Ningbo Runyes Medical Instrument Co., Ltd.: FDA-registered device maker in Ningbo Zhejiang, China, 4 510(k) clearances

Name: Ningbo Runyes Medical Instrument Co., Ltd. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Ningbo Runyes Medical Instrument Co., Ltd. is registered with the FDA (registration 3008252267) in Ningbo Zhejiang, China. It lists 4 device types. The FDA files 4 510(k) clearances under its listings, the newest dated February 3, 2026. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3008252267
Address: No. 456 Tonghui Road Jiangbei Investment & Pioneering Park C, Ningbo Zhejiang, China, 315033
Owner or operator: Ningbo Runyes Medical Instrument Co., Ltd. (10052869)
Roles: Complaint file establishment, Contract manufacturer, Exporter to the US, Foreign private label distributor, Manufacturer, Repackager or relabeler
First device listed: October 13, 2016
Registered through: 2026
Brand names listed: All-in-one Photogrammetry Camera iGrapher Trinity, Diagnostic X-Ray Equipment MobileX R98, Diagnostic X-Ray Equipment POCT22, Diagnostic X-Ray Equipment RAY88(P), Diagnostic X-Ray Equipment RAY98(P), Intraoral Scanner 3DS Mega, Intraoral Scanner 3DS Ultra, Intraoral Scanner ORAL-O3 and more

Devices it lists

Device	Product code	Class	Role	Source
Intraoral Camera	QJK	2	Complaint file establishment, Contract manufacturer, Manufacturer	accessdata.fda.gov
System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations	NOF	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
System, X-Ray, Extraoral Source, Digital	MUH	2	Exporter to the US, Foreign private label distributor, Repackager or relabeler	accessdata.fda.gov
Unit, X-Ray, Extraoral With Timer	EHD	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
February 3, 2026	K252909	Diagnostic X-Ray Equipment Model POCT22	EHD	Substantially Equivalent	Ningbo Runyes Medical Instrument Co., Ltd.	accessdata.fda.gov
July 13, 2023	K231449	Portable X-ray System Model Ray98(P)	EHD	Substantially Equivalent	Ningbo Runyes Medical Instrument Co., Ltd.	accessdata.fda.gov
April 23, 2021	K210312	PlutoX Digital Intraoral X-Ray Imaging System	MUH	Substantially Equivalent	Iray Technology Taicang , Ltd.	accessdata.fda.gov
December 7, 2012	K122582	DENTAL X-RAY Z70 (W); DENTAL X-RAY Z70 (M); DENTAL X-RAY Z70 (C)	EHD	Substantially Equivalent	Denterprise International, Inc.	accessdata.fda.gov

Compare with other makers

Updated February 3, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.