FDA Registration
Inactive
🇨🇳 China
SiYi, Water soluble human lubricant, Model: TOFKE-500ml, TOFKE-250ml, TOFKE-150ml, TOFKE-100ml, TOFKE-30ml, TOFKE-5ml
·
Expires 2025
Products
1
Proprietary Names
3
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- DONGGUAN YANXUAN BIOTECHNOLOGY CO., LTD
- Status
- Inactive
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Room 203, No. 509, Shenyuan 1st Lane, Qiaotou Town
- City
- Dongguan City Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K243107
Owner / Operator
- Firm Name
- Dongguan Yanxuan Biotechnology Co., Ltd
- Operator Number
- 10093620
- Address
- Room 203, No. 509, Shenyuan 1st Lane, Qiaotou Town
- City
- Dongguan City
- State
- Guangdong
- Postal Code
- 523539
- Country
- CN
- Correspondent
- Long Wang
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Lubricant, Personal | NUC | Class 2 | Obstetrics/Gynecology | No | 2025-06-13 |
Proprietary Names
SiYi, Water soluble human lubricant, Model: TOFKE-500ml, TOFKE-250ml, TOFKE-150ml, TOFKE-100ml, TOFKE-30ml, TOFKE-5ml
SiYi, Water soluble human lubricant, Model: ITMT-10ml, ITMT-30ml, ITMT-50ml, ITMT-120ml, ITMT-300ml, ITMT-500ml
SiYi, Water soluble human lubricant, Model: 50ml, 100ml, 150ml, 200ml, 220ml, 250ml, 300ml
Establishment Types
Manufacture Medical Device