Data / Medical devices / China / Suzhou Yuyue Medical Technology Co., Ltd
Suzhou Yuyue Medical Technology Co., Ltd: FDA-registered device maker in Suzhou Jiangsu, China, 1 510(k) clearance
Suzhou Yuyue Medical Technology Co., Ltd is registered with the FDA (registration 3016710298) in Suzhou Jiangsu, China. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated July 2, 2021. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3016710298
- Address
- No. 9 Jinfeng Road, Suzhou Science & Technology Town, Suzhou Jiangsu, China, 215163
- Owner or operator
- SUZHOU YUYUE MEDICAL TECHNOLOGY CO., LTD (10091669)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- October 22, 2024
- Registered through
- 2026
- Brand names listed
- Headgear, YUWELL Standard conical connector, Yuwell Sleep Apnea Breathing Therapy Mask
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Connector, Airway (Extension) | BZA | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Mask, Oxygen, Low Concentration, Venturi | BYF | 1 | Manufacturer | accessdata.fda.gov |
| Strap, Head, Gas Mask | BTK | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Ventilator, Non-Continuous (Respirator) | BZD | 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 |
|---|---|---|---|---|---|---|
| July 2, 2021 | K203347 | Sleep Apnea Breathing Therapy Mask: YF-01 Full Face Mask, YF-02 Full Face Mask, YF-03 Full Face Mask, YN-02 Nasal Mask, YN-03 Nasal Mask, YP-01 Nasal Pillow Mask | BZD | Substantially Equivalent | Suzhou Yuyue Medical Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Ventilator, Non-Continuous (Respirator)
- All makers of Mask, Oxygen, Low Concentration, Venturi
- All makers of Strap, Head, Gas Mask
- All makers of Connector, Airway (Extension)
Updated July 2, 2021. 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.