Manufacturer registered with FDA
Ningbo Runyes Medical Instrument Co., Ltd.
Ningbo, China. Lists 4 dental device types with FDA across 1 registered establishment, and holds 2 510(k) clearances as applicant.
- Device types listed
- 4
- Brands and models
- 25
- 510(k) clearances
- 22023–2026
- Markets registered in
- 13116 registrations outside the US
- Establishments
- 1China
510(k) clearances per year, 2007–2026
Registered in 13 markets
Where regulators' registries name Ningbo Runyes Medical Instrument Co., Ltd. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Ningbo Runyes Medical Instrument Co., Ltd. | 2 clearances | 2023–2026 | Below |
| European Union | EUDAMED | Manufacturer | Ningbo Runyes Medical Instrument Co., Ltd. | 28 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Ningbo Runyes Medical Instrument Co., Ltd.Ningbo Runyes Medical Instrument Co. Ltd | 16 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Ningbo Runyes Medical Instrument Co Ltd | 13 | 2007–2026 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | Ningbo Runyes Medical Instrument Co., LTD. | 12 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | NINGBO RUNYES MEDICAL INSTRUMENT CO., LTD.NINGBO RUNYES MEDICAL INSTRUMENT CO., LTD · Ningbo Runyes Medical Instrument Co., Ltd. | 12 | 2009–2026 | Pure Global AI |
| South Korea | MFDS | Manufacturer | Ningbo RunyesMedical Instrument Co., Ltd.Ningbo Runyes Medical Instrument Co., Ltd. · NINGBO RUNYES MEDICAL INSTRUMENT CO., LTD · +2 | 10 | 2008–2026 | Pure Global AI |
| Peru | DIGEMID | Manufacturer | NINGBO RUNYES MEDICAL INSTRUMENT CO., LTD. | 6 | 2023–2024 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | NINGBO RUNYES MEDICAL INSTRUMENT CO., LTD. | 5 | 2023–2026 | Pure Global AI |
| Israel | AMAR | Manufacturer | NINGBO RUNYES MEDICAL INSTRUMENT CO., LTD.Ningbo Runyes Medical Instrument Co., Ltd. · Ningbo Runyes Medical Instrument Co., Ltd | 5 | — | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | Ningbo Runyes Medical Instrument Co., Ltd. | 4 | — | Pure Global AI |
| Serbia | ALIMS | Manufacturer | Ningbo Runyes Medical Instrument Co., Ltd. | 3 | 2024–2024 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | NINGBO RUNYES MEDICAL INSTRUMENT CO., LTDNINGBO RUNYES MEDICAL INSTRUMENT CO., LTD. | 2 | — | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Ningbo Runyes Medical Instrument Co., Ltd. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Extraoral with Timer X-Ray UnitEHD · Class 2 | Dental X-ray units | Maker | Diagnostic X-Ray Equipment MobileX R98Diagnostic X-Ray Equipment POCT22Diagnostic X-Ray Equipment RAY88(P)Diagnostic X-Ray Equipment RAY98(P)X-Ray Diagnostic Equipment RAY68 (M)X-Ray Diagnostic Equipment RAY68 (W) | 2016 |
| Digital Extraoral Source X-Ray SystemMUH · Class 2 | Dental X-ray units | Lister | Runyes Dental Digital Imaging Sensor | 2025 |
| Computer Assisted Design and Manufacturing (Cad/Cam) of Dental Restorations Optical Impression SystemNOF · Class 2 | Intraoral scanners | Maker | All-in-one Photogrammetry Camera iGrapher ProAll-in-one Photogrammetry Camera iGrapher TrinityIntraoral Scanner 3DS MegaIntraoral Scanner 3DS UltraIntraoral Scanner ORAL-O3Intraoral Scanner R2i3Intraoral Scanner SCAN-i5Intraoral Scanner SCAN-i6Intraoral Scanner SCAN-O5Intraoral Scanner SCAN-O6 7 moreIntraoral Scanner SCAN-V5Intraoral Scanner SCAN-V6Intraoral Scanner SCAN11Intraoral Scanner SCAN33Photogrammetry Camera iGrapherQuickScanIOSRunyes 3DS Intraoral Scanner IOS-11 | 2018 |
| Intraoral CameraQJK · Class 2 | Intraoral cameras | Maker | TeliCam | 2024 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Ningbo Runyes Medical Instrument Co., Ltd. as the applicant.
Also lists devices cleared under other names
Ningbo Runyes Medical Instrument Co., Ltd. lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Iray Technology Taicang , Ltd. (1), Denterprise International, Inc (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 23 Apr 2021 | K210312 | PlutoX Digital Intraoral X-Ray Imaging System | Iray Technology Taicang , Ltd. | MUH Digital Extraoral Source X-Ray System |
| 7 Dec 2012 | K122582 | DENTAL X-RAY Z70 (W); DENTAL X-RAY Z70 (M); DENTAL X-RAY Z70 (C) | Denterprise International, Inc | EHD Extraoral with Timer X-Ray Unit |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| Ningbo Runyes Medical Instrument Co., Ltd.FDA reg. 3008252267 | Ningbo Zhejiang, China | Foreign exporter, Manufacturer, Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10052869). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.