Data / Medical devices / China / BATH CONCEPTS COSMETICS (DongGuan) Co., LTD
BATH CONCEPTS COSMETICS (DongGuan) Co., LTD: FDA-registered device maker in DongGuan Guangdong, China, 1 510(k) clearance
BATH CONCEPTS COSMETICS (DongGuan) Co., LTD is registered with the FDA (registration 3008080893) in DongGuan Guangdong, China. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated April 14, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008080893
- Address
- No.1 Nange 5th Road,Daojiao Town, DongGuan Guangdong, China, 523170
- Owner or operator
- Bath Concepts Cosmetics (10041753)
- Roles
- Exporter to the US, Manufacturer, Repackager or relabeler
- First device listed
- October 26, 2020
- Registered through
- 2026
- Brand names listed
- BRAZZERS ULTRA SLICK PREMIUM SILICONE LUBRICANT, First Release Silicone-based Personal Lubricant, Inhaler, Intimaterial Silicone Personal Lubricant, LubeLab Premium Silicone-based Personal Lubricant, MEN SHINE SILICONE LUBRICANT, SILICONE Personal Lubricant, Silicone Based Premium Lubricant-Lubefy and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Lubricant, Personal | NUC | 2 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Nasal Spray, Ent Delivery | KCO | 1 | Exporter to the US, 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 |
|---|---|---|---|---|---|---|
| April 14, 2020 | K191654 | SILICONE Personal Lubricant | NUC | Substantially Equivalent | Bath Concept Cosmetics (Dongguan) Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated April 14, 2020. 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.