FDA Registration
Active
🇨🇳 China
Nio Color 3MP
Reg #: 3024137003
·
FEI: 3024137003
·
Expires 2025
Products
1
Proprietary Names
4
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Barco (Suzhou) Healthcare Technology Co., Ltd.
- Registration Number
- 3024137003
- FEI Number
- 3024137003
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- No.111, Sutong Road, Suzhou Industrial Park
- City
- Suzhou Jiangsu
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K230520
Owner / Operator
- Firm Name
- BARCO NV
- Operator Number
- 9031117
- Address
- Beneluxpark 21
- City
- Kortrijk
- State
- West-Vlaanderen
- Postal Code
- 8500
- Country
- BE
US Agent
- Business Name
- Barco Inc.
- Contact Name
- Roxana Allen
- Address
- 3059 Premiere Parkway,Suite 400
- City
- Duluth
- State
- GA
- ZIP
- 30097
- Country
- US
- [email protected]
- Phone
- 678 2008674
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Display, Diagnostic Radiology | PGY | Class 2 | Radiology | No | 2023-04-24 |
Proprietary Names
Nio Color 3MP
Nio Color 2MP
MDNC-3521
MDNC-2521
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)