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Data / Medical devices / China / Shenzhen Gel Word Medical Devices Co., Ltd.

Shenzhen Gel Word Medical Devices Co., Ltd.: FDA-registered device maker in Shenzhen Guangdong, China, 1 510(k) clearance

Shenzhen Gel Word Medical Devices Co., Ltd. is registered with the FDA (registration 3042254987) in Shenzhen Guangdong, China. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated September 9, 2025. 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
3042254987
Address
02/F, Building 3, Baiwangda Health Technology Industrial Park Shanshui Second Road, Dakang Community, Yuanshan Street, Longgang District, Shenzhen Guangdong, China, 518100
Owner or operator
Shenzhen Yongquan Medical Devices Co., Ltd. (10094166)
Roles
Manufacturer
First device listed
November 17, 2025
Registered through
2026
Brand names listed
Arousellube Hyaluronic acid lubricant 3g*10Stick, Arousellube VITAMINE flavor lubricant 125g,Arousellube Strawberry flavor lubricant 100g, DRYWELL vitamin E Lubricant ,200ml,220ml; KAOTIKLABS VE water based lubricant 150ml; loob water based lubricant 250ml, HANIDOLL Strawberry Lubricant 16oz; HANIDOLL vitamin E Lubricant 16oz; NO FORGET LOVE vitamin E Lubricant 200ml;, Oye Joy Dew Lychee WATER-BASED PERSONAL LUBE 3.5Fl.oz 100ml;, Oye Joy Silky Cherry WATER-BASED PERSONAL LUBE 3.5Fl.oz 100ml, Pinknight Strawberry Lubricant 100ml; Pinknight caramel Lubricant 100ml; Pinknight peach Lubricant 100ml;, RAW TOUCH Caramel Lubricant 300ml; RAW TOUCH Strawberry Lubricant 300ml; RAW TOUCH vitamin E Lubricant 300ml,500ml; and more

Devices it lists

DeviceProduct codeClassRoleSource
Lubricant, PersonalNUC2Manufactureraccessdata.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.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
September 9, 2025K251773Water-soluble Personal Lubricant (Satin Gel Vitamin E flavor lubricant; Satin Gel Caramel flavor lubricant; Satin Gel Peach flavor lubricant; Satin Gel Strawberry flavor lubricant.)NUCSubstantially EquivalentShenzhen Yongquan Medical Devices Co., Ltd.accessdata.fda.gov

Compare with other makers

Updated September 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.