Ningbo Runyes Medical Instrument Co., Ltd.
Registered establishment in Ningbo, Zhejiang, China. 4 device types, 2 clearances.
Ningbo Runyes Medical Instrument Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Intraoral Camera, Unit, X-Ray, Extraoral With Timer and 2 other device types. Its earliest product listing with the FDA dates from 2016.
Registration
| Status | Registered |
|---|---|
| Registration expires | 2026 |
| Registration number | 3008252267 |
| FEI number | 3008252267 |
| Establishment type | Contract manufacturer, Repacker / relabeller, Private-label distributor, Complaint-file establishment, Manufacturer, Exporter |
Chinese Registration
| Chinese legal name | 宁波蓝野医疗器械有限公司 |
|---|---|
| Source | customs registration record |
Location
| City | Ningbo |
|---|---|
| Province | Zhejiang |
| Address | No. 456 Tonghui Road |
| Postal code | 315033 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Intraoral Camera | Class 2 | TeliCam | 2024 | 6 |
| System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations | Class 2 | Runyes 3DS Intraoral Scanner IOS-11, Intraoral Scanner SCAN-i6, Intraoral Scanner SCAN-i5, QuickScanIOS, Photogrammetry Camera iGrapher, Intraoral Scanner SCAN-V6 and 10 more | 2018 | 36 |
| System, X-Ray, Extraoral Source, Digital | Class 2 | Runyes Dental Digital Imaging Sensor | 2025 | 10 |
| Unit, X-Ray, Extraoral With Timer | Class 2 | Diagnostic X-Ray Equipment RAY88(P), Diagnostic X-Ray Equipment RAY98(P), Diagnostic X-Ray Equipment MobileX R98, X-Ray Diagnostic Equipment RAY68 (M), X-Ray Diagnostic Equipment RAY68 (W), Diagnostic X-Ray Equipment POCT22 | 2016 | 8 |
Clearances
2 clearances name Ningbo Runyes Medical Instrument Co., Ltd. as applicant. 2 are held by other companies and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K252909 | 2026-02-03 | EHD | Traditional | This company |
| K231449 | 2023-07-13 | EHD | Traditional | This company |
| K210312 | 2021-04-23 | MUH | Traditional | Iray Technology Taicang, Ltd. |
| K122582 | 2012-12-07 | EHD | Traditional | Denterprise International, Inc. |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2000 |
|---|---|
| Main products | Dental units, Intraoral scanners, Sterilizers, Imaging equipment, Digital products |
| Export markets | 100+ countries and regions |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.