FDA Registration
Active
🇨🇳 China
Shenzhen Gel Word Medical Devices Co., Ltd.
Reg #: 3042254987
·
FEI: 3042254987
·
Expires 2026
Products
1
Proprietary Names
11
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Shenzhen Gel Word Medical Devices Co., Ltd.
- Registration Number
- 3042254987
- FEI Number
- 3042254987
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 02/F, Building 3, Baiwangda Health Technology Industrial Park, Shanshui Second Road, Dakang Community, Yuanshan Street, Longgang District
- City
- Shenzhen Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K251773
Owner / Operator
- Firm Name
- Shenzhen Yongquan Medical Devices Co., Ltd.
- Operator Number
- 10094166
- Address
- 2nd Floor, Building 3, Guangqi Future Technology Park, No. 18 Shanshui 2nd Road, Dakang Community, Yuanshan Street, Longgang District,
- City
- Shenzhen
- State
- Guangdong
- Postal Code
- 518100
- Country
- CN
- Correspondent
- Pei Ye
US Agent
- Business Name
- Innovasure INC
- Contact Name
- Asher Cheng
- Address
- 17870 Castleton St Ste 363
- City
- City Industry
- State
- CA
- ZIP
- 91748
- Country
- US
- [email protected]
- Phone
- 678 8026200
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Lubricant, Personal | NUC | Class 2 | Obstetrics/Gynecology | No | 2025-11-17 |
Proprietary Names
Arousellube Hyaluronic acid lubricant 3g*10Stick
RAW TOUCH Caramel Lubricant 300ml; RAW TOUCH Strawberry Lubricant 300ml; RAW TOUCH vitamin E Lubricant 300ml,500ml;
Pinknight Strawberry Lubricant 100ml; Pinknight caramel Lubricant 100ml; Pinknight peach Lubricant 100ml;
Oye Joy Dew Lychee WATER-BASED PERSONAL LUBE 3.5Fl.oz 100ml;
satin gel Caramel Lubricant 200ml; satin gel Strawberry Lubricant 200ml; satin gel vitamin E 200ml;
satin gel peach Lubricant 200ml; SVAKOM VE water based lubricant 150ml;
Oye Joy Silky Cherry WATER-BASED PERSONAL LUBE 3.5Fl.oz 100ml
DRYWELL vitamin E Lubricant ,200ml,220ml; KAOTIKLABS VE water based lubricant 150ml; loob water based lubricant 250ml
Syronos personal lubricant 10.5FL.Oz/300g
HANIDOLL Strawberry Lubricant 16oz; HANIDOLL vitamin E Lubricant 16oz; NO FORGET LOVE vitamin E Lubricant 200ml;
Arousellube VITAMINE flavor lubricant 125g,Arousellube Strawberry flavor lubricant 100g
Establishment Types
Manufacture Medical Device