Xiamen Yizhou IMP. & EXP. Co., Ltd.
Registered establishment in Xiamen, Fujian, China. 10 device types, 1 clearance.
Xiamen Yizhou IMP. & EXP. Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Dilator, Nasal, Protector, Dental and 8 other device types. Its earliest product listing with the FDA dates from 2016.
Registration
| Registered name | XIAMEN YIZHOU IMP. & EXP. CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3008763803 |
| FEI number | 3008763803 |
| Establishment type | Contract manufacturer, Manufacturer, Exporter |
Location
| City | Xiamen |
|---|---|
| Province | Fujian |
| Address | 201,2F,Huili Industrial Park,Meixi Rd.,Tong An District, |
| Postal code | 361100 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Accessories, Implant, Dental, Endosseous | Class 1 | plastic case | 2023 | 70 |
| Device, Anti-Snoring | Class 2 | Dormiva Anti-Snoring Mouth Guard, Tranquility PRO 2 Anti-Snoring Mouth Guard, Somnos Anti-Snoring Mouth Guard, Tranquility, Eliminator Pro 2, Somnos Pro 2 and 8 more | 2021 | 8 |
| Device, Jaw Repositioning | Class 2 | Dormiva Anti-Snoring Mouth Guard, Tranquility PRO 2 Anti-Snoring Mouth Guard, Somnos Anti-Snoring Mouth Guard, Tranquility, Eliminator Pro 2, Somnos Pro 2 and 7 more | 2021 | 4 |
| Dilator, Nasal | Class 1 | Nasal Dilator | 2016 | 55 |
| Disinfectant, Medical Devices | Class 1 | Eliminator Box | 2020 | 197 |
| Heat Source For Bleaching Teeth | Class 1 | teeth whitening LED light;teeth whitening light; teeth whitening mouth tray LED light;teeth whitening accelerator | 2018 | 56 |
| Mouthguard, Over-The-Counter | Class U | DABIDA Mouth Guard, UNIEDI Mouth Guard, ClenchNoMore, LIFEWAY Mouth Guard, Stafenit Mouth Guard,LOPIANY Mouth Guard,Litlcutie Anti Grinding Guard, Anti Grinding Guard and 7 more | 2019 | 4 |
| Protector, Dental | Class 1 | GuardianZPro | 2020 | 11 |
| Retractor, All Types | Class 1 | Cheek Retractor | 2016 | 45 |
| Tray, Impression, Preformed | Class 1 | Anti Snore Mouth Tray, Impression Mouth Tray(For grinding,TeethWhitening), Mouthguard | 2016 | 73 |
Clearances
1 clearance names Xiamen Yizhou IMP. & EXP. Co., Ltd. as applicant. 1 is held by another company 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 |
|---|---|---|---|---|
| K240810 | 2024-05-24 | OBR | Traditional | This company |
| K201484 | 2020-11-23 | LRK | Traditional | Koncept Innovators, LLC |
From the Company
Published by the company on its own website, not by the FDA.
| Factory area | 3000 |
|---|---|
| Main products | Silicone rubber products, Plastic products, Mould design, Mouth guards, Sports products |
| Export markets | Amazon health, fashion and sports categories; international markets |
| OEM and ODM | Offered |
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.