FDA Registration
Active
🇨🇳 China
Klarity Bolus
Reg #: 3003803149
·
FEI: 3003803149
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- KLARITY MEDICAL & EQUIPMENT (GZ) CO., LTD.
- Registration Number
- 3003803149
- FEI Number
- 3003803149
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- No. 6, Bihua Street, Huangpu District
- City
- Guangzhou Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K202747
Owner / Operator
- Firm Name
- KLARITY MEDICAL & EQUIPMENT (GZ) CO, LTD.
- Operator Number
- 9050591
- Address
- No. 6, Bihua Street, Huangpu District
- City
- Guangzhou
- State
- Guangdong
- Postal Code
- 510730
- Country
- CN
- Correspondent
- Michelle P Fritch
US Agent
- Business Name
- Klarity Medical Products, LLC
- Contact Name
- PETER LARSON
- Address
- 600 Industrial Parkway
- City
- Heath
- State
- OH
- ZIP
- 43056
- Country
- US
- [email protected]
- Phone
- 740 7888107 ext. 111
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Accelerator, Linear, Medical | IYE | Class 2 | Radiology | No | 2021-06-03 |
Proprietary Names
Klarity Bolus
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device