Data / Medical devices / China / Xiamen Yizhou Imp. & Exp. Co., Ltd.
Xiamen Yizhou Imp. & Exp. Co., Ltd.: FDA-registered device maker in Xiamen Fujian, China, 2 510(k) clearances
Xiamen Yizhou Imp. & Exp. Co., Ltd. is registered with the FDA (registration 3008763803) in Xiamen Fujian, China. It lists 10 device types. The FDA files 2 510(k) clearances under its listings, the newest dated May 24, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008763803
- Address
- 201,2F,Huili Industrial Park,Meixi Rd.,Tong An District, Xiamen Fujian, China, 361100
- Owner or operator
- Xiamen Yizhou Imp. & Exp. Co., Ltd. (10053196)
- Roles
- Contract manufacturer, Exporter to the US, Manufacturer
- First device listed
- November 8, 2016
- Registered through
- 2026
- Brand names listed
- Anti Grinding Guard, Anti Snore Mouth Tray, Bright Guard, Bright Guard Pro 2, Cheek Retractor, ClenchNoMore, DABIDA Mouth Guard, Dormiva Anti-Snoring Mouth Guard and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Implant, Dental, Endosseous | NDP | 1 | Contract manufacturer, Exporter to the US | accessdata.fda.gov |
| Device, Anti-Snoring | LRK | 2 | Contract manufacturer, Exporter to the US | accessdata.fda.gov |
| Device, Jaw Repositioning | LQZ | 2 | Contract manufacturer, Exporter to the US | accessdata.fda.gov |
| Dilator, Nasal | LWF | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Disinfectant, Medical Devices | LRJ | 1 | Contract manufacturer | accessdata.fda.gov |
| Heat Source For Bleaching Teeth | EEG | 1 | Contract manufacturer | accessdata.fda.gov |
| Mouthguard, Over-The-Counter | OBR | U | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Protector, Dental | BRW | 1 | Contract manufacturer, Exporter to the US | accessdata.fda.gov |
| Retractor, All Types | EIG | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Tray, Impression, Preformed | EHY | 1 | Contract 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 |
|---|---|---|---|---|---|---|
| May 24, 2024 | K240810 | Anti Grinding Guard | OBR | Substantially Equivalent | Xiamen Yizhou Imp. & Exp. Co., Ltd. | accessdata.fda.gov |
| November 23, 2020 | K201484 | Somnos Anti-Snoring Mouth Guard | LRK | Substantially Equivalent | Koncept Innovators, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Mouthguard, Over-The-Counter
- All makers of Tray, Impression, Preformed
- All makers of Heat Source For Bleaching Teeth
- All makers of Device, Anti-Snoring
- All makers of Device, Jaw Repositioning
- All makers of Retractor, All Types
Updated May 24, 2024. 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.