FDA Registration
Active
🇨🇳 China
TRUDERMAL Halo
Reg #: 3011644607
·
FEI: 3011644607
·
Expires 2025
Products
1
Proprietary Names
3
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- Shenzhen Kaiyan Medical Equipment Co., Ltd
- Registration Number
- 3011644607
- FEI Number
- 3011644607
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Building#3 and Building#5, 40th of Fuxin Street, Huaide Community Fuyong Town, BaoAn District
- City
- Shenzhen Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K242363
Owner / Operator
- Firm Name
- Shenzhen Kaiyan Medical Equipment Co., Ltd
- Operator Number
- 10049428
- Address
- Building#3 and Building#5, 40th of Fuxin Street, Huaide Community, Fuyong Town ,, Bao'An District
- City
- Shenzhen
- State
- Guangdong
- Postal Code
- 518103
- Country
- CN
- Correspondent
- Alain Dijkstra
US Agent
- Business Name
- Light Tree Ventures USA LLC
- Contact Name
- Kim Markwat
- Address
- 6240 NE 4TH CT
- City
- Miami
- State
- FL
- ZIP
- 33138
- Country
- US
- [email protected]
- Phone
- 786 6471640
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Laser, Comb, Hair | OAP | Class 2 | Physical Medicine | No | 2025-01-03 |
Proprietary Names
TRUDERMAL Halo
HIGHERDOSE RED LIGHT HAT
RIKI LOVES RIKI HAIR GROWTH CAP
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device