Data / Medical devices / China / Shenzhen Guangdian Technology Co., Ltd
Shenzhen Guangdian Technology Co., Ltd: FDA-registered device maker in Shenzhen Guangdong, China, 1 510(k) clearance
Shenzhen Guangdian Technology Co., Ltd is registered with the FDA (registration 3021033518) in Shenzhen Guangdong, China. It lists 3 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.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3021033518
- Address
- 501, Area A, Building A, Jingfazhi Building, Xiawei Park, Gushu Community, Xixiang Street, Bao'an District, Shenzhen Guangdong, China, 518000
- Owner or operator
- Shenzhen Guangdian Technology Co., Ltd (10083084)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- October 25, 2021
- Registered through
- 2026
- Brand names listed
- Anal Sex Toys, Dildos, Masturbators, Masturbators & Dolls, Penis Rings, Pumps & Enlargers, Vibrators, personal lubricant and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Lubricant, Personal | NUC | 2 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Massager, Therapeutic, Electric | ISA | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Massager, Therapeutic, Manual | LYG | 1 | Manufacturer, Repackager or relabeler | 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
- All makers of Massager, Therapeutic, Electric
- All makers of Massager, Therapeutic, Manual
- All makers of Lubricant, Personal
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.