Data / Medical devices / China / Dongguan Yanxuan Biotechnology Co., Ltd
Dongguan Yanxuan Biotechnology Co., Ltd: FDA-registered device maker in Dongguan City Guangdong, China, 1 510(k) clearance
Dongguan Yanxuan Biotechnology Co., Ltd is registered with the FDA (registration 3038613112) in Dongguan City Guangdong, China. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated May 9, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3038613112
- Address
- Room 203, No. 509, Shenyuan 1st Lane, Qiaotou Town, Dongguan City Guangdong, China, 523539
- Owner or operator
- Dongguan Yanxuan Biotechnology Co., Ltd (10093620)
- Roles
- Manufacturer
- First device listed
- June 13, 2025
- Registered through
- 2026
- Brand names listed
- BEISAR, Water Solubility Human Body Lubricant, Model: 240ml, Mrgras, Water Solubility Human Body Lubricant, Model: 8ml, 20ml, 120ml, 200ml, 240ml, 250ml, 300ml, 480ml, SiYi, Water Solubility Human Body Lubricant, Model: 50ml, 100ml, 150ml, 200ml, 220ml, 250ml, 300ml, SiYi, Water Solubility Human Body Lubricant, Model: 50ml, 150ml, 500ml,150ml, SiYi, Water Solubility Human Body Lubricant, Model: Acmejoy-10ml, Acmejoy-100ml, Acmejoy-120ml, Acmejoy-150ml, SiYi, Water Solubility Human Body Lubricant, Model: Acmejoy-200ml, Acmejoy-240ml, Acmejoy-300ml, SiYi, Water Solubility Human Body Lubricant, Model: Anosoothe+ Lubricant 300ml, Anosoothe+ Lubricant 500ml, SiYi, Water Solubility Human Body Lubricant, Model: AquaLuxe Lubricant 150ml, AquaLuxe Lubricant 300ml and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Lubricant, Personal | NUC | 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 |
|---|---|---|---|---|---|---|
| May 9, 2025 | K243107 | Water Solubility Human Body Lubricant | NUC | Substantially Equivalent | Dongguan Yanxuan Biotechnology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated May 9, 2025. 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.