FDA Registration
Active
🇨🇳 China
Pure Adapt
Reg #: 3030233762
·
FEI: 3030233762
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- CYDEN MEDICAL TECHNOLOGY (ZHEJIANG) CO., LTD
- Registration Number
- 3030233762
- FEI Number
- 3030233762
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- East of Building C No289, Songhai Road, Huimin District, Jiashan, Zhejiang, China
- City
- Jiashan Zhejiang
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K233782
Owner / Operator
- Firm Name
- Cyden Medical Technology (Zhejiang) Co., Ltd
- Operator Number
- 10089142
- Address
- East of Building C No289, Songhai Road, Huimin District, Jiashan, Zhejiang China
- City
- Jiashan
- State
- Zhejiang
- Postal Code
- 314100
- Country
- CN
- Correspondent
- Luxia Zhao
US Agent
- Business Name
- METRO-PACK, INC
- Contact Name
- John Sgombick
- Address
- 37 JEANNE DRIVE, NEWBURGH, NY, Newburgh, NY 12550 US
- City
- Newburgh
- State
- NY
- ZIP
- 12550
- Country
- US
- [email protected]
- Phone
- 845 5645275
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Light Based Over-The-Counter Hair Removal | OHT | Class 2 | General, Plastic Surgery | No | 2024-08-15 |
Proprietary Names
Pure Adapt
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device