FDA Registration
Active
🇨🇳 China
MANTEIA TECHNOLOGIES CO.,LTD.
Reg #: 3016686005
·
FEI: 3016686005
·
Expires 2026
Products
3
Proprietary Names
6
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- MANTEIA TECHNOLOGIES CO.,LTD.
- Registration Number
- 3016686005
- FEI Number
- 3016686005
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Unit 3001-3005, No.5 Huizhan North Road
- City
- Xiamen Fujian
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K223834
Owner / Operator
- Firm Name
- Manteia Technologies Co.,Ltd.
- Operator Number
- 10062831
- Address
- Unit 3001-3005, No.5 Huizhan North Road
- City
- Xiamen
- State
- Fujian
- Postal Code
- 361000
- Country
- CN
- Correspondent
- Chao Fang
US Agent
- Business Name
- MID-LINK INTERNATIONAL CO., LTD
- Contact Name
- Marco Mu
- Address
- 2219 Rimlang Drive, Suite 301
- City
- Bellingham
- State
- WA
- ZIP
- 98226
- Country
- US
- [email protected]
- Phone
- 702 2095185
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Accelerator, Linear, Medical | IYE | Class 2 | Radiology | No | 2023-07-21 |
| Radiological Image Processing Software For Radiation Therapy | QKB | Class 2 | Radiology | No | 2026-04-22 |
| System, Planning, Radiation Therapy Treatment | MUJ | Class 2 | Radiology | No | 2023-07-13 |
Proprietary Names
AccuCheck Radiotherapy Plan Quality Assurance System
AccuCheck
AccuContour 4
AccuContour
ARTAssistant
MOZI TPS
Establishment Types
Manufacture Medical Device