FDA Registration
Active
🇨🇳 China
iRay Imaging Technology Taicang Limited
Reg #: 3014544225
·
FEI: 3014544225
·
Expires 2026
Products
3
Proprietary Names
26
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- iRay Imaging Technology Taicang Limited
- Registration Number
- 3014544225
- FEI Number
- 3014544225
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- No.33 Xinggang Road, Taicang Port Economic and Technological Development Zone
- City
- Taicang Jiangsu
- Country
- CN
Owner / Operator
- Firm Name
- iRay Imaging Technology Taicang Limited
- Operator Number
- 10058988
- Address
- No. 33, Xinggang Road, Taicang Port Economic and Technological Development Zone
- City
- Taicang
- State
- Jiangsu
- Postal Code
- 215434
- Country
- CN
- Correspondent
- Wei Pan
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 |
|---|---|---|---|---|---|
| System, X-Ray, Extraoral Source, Digital | MUH | Class 2 | Dental | No | 2023-11-13 |
| Solid State X-Ray Imager (Flat Panel/Digital Imager) | MQB | Class 2 | Radiology | No | 2021-03-11 |
| System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations | NOF | Class 2 | Dental | No | 2026-01-12 |
Proprietary Names
Pluto0002XW
Mars1417X Wireless Digital Flat Panel Detector
Mano4336F Wireless Digital Flat Panel Detector
Mano4336A Wireless Digital Flat Panel Detector
Mars1417V-TSI & Mano4336W
CS 6200 Digital Intraoral X-Ray Sensor
Mars1717XF-CSI
Luna1012X Wireless Digital Flat Panel Detector
Mano2530A Wireless Digital Flat Panel Detector
Mano2530F Wireless Digital Flat Panel Detector
Mercu1717V
Focus HD 35 Detector
TRIMAX 35C
Focus 35C
Lux HD 35/43
Mars1717V-VSI and Mano4343W
Focus HD 43 Detector
Mars1013X
Venu1717X
Mars1717X Wireless Digital Flat Panel Detector
Mano4343A Wireless Digital Flat Panel Detector
Mano4343F Wireless Digital Flat Panel Detector
Mars1717XF-GSI
Focus 43C; TRIMAX 43C
PlutoX Digital Intraoral X-ray Imaging System
iScan
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)