FDA Registration
Active
🇨🇳 China
FLARE single-use surgical laser fiber
Reg #: 3019906161
·
FEI: 3019906161
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Realton (Suzhou) Medical Technology Co., Ltd.
- Registration Number
- 3019906161
- FEI Number
- 3019906161
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 601 Room, B8 Building, 218 Xinghu Road, Suzhou Industrial Park, Suzhou,
- City
- Suzhou Jiangsu
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K202702
Owner / Operator
- Firm Name
- Realton (Suzhou) Medical Technology Co., Ltd.
- Operator Number
- 10082212
- Address
- 601 Room, B8 Building, 218 Xinghu Road, Suzhou Industrial Park
- City
- Suzhou
- State
- Jiangsu
- Postal Code
- 215123
- Country
- CN
- Correspondent
- Mingzhu Liu
US Agent
- Business Name
- OSMUNDA TECHNOLOGY CO., LTD.
- Contact Name
- Cancan Huang
- Address
- 949 White River Dr Allen
- City
- Allen
- State
- TX
- ZIP
- 75013
- Country
- US
- [email protected]
- Phone
- 858 3571157
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Powered Laser Surgical Instrument | GEX | Class 2 | General, Plastic Surgery | No | 2021-06-29 |
Proprietary Names
FLARE single-use surgical laser fiber
Establishment Types
Manufacture Medical Device