FDA Registration
Active
🇰🇷 South Korea
IRAY KOREA LIMITED
Reg #: 3015464948
·
FEI: 3015464948
·
Expires 2026
Products
3
Proprietary Names
26
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- IRAY KOREA LIMITED
- Registration Number
- 3015464948
- FEI Number
- 3015464948
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1833, 18F, 5, Gasan digital 1-ro, Geumcheon-gu, Seoul, Republic of Korea 08594
- City
- Seoul
- Country
- KR
Owner / Operator
- Firm Name
- iRay Korea Limited
- Operator Number
- 10060342
- Address
- 1833, 18F, 5, Gasan digital 1-ro, Geumcheon-gu, Seoul, Republic of Korea 08594
- City
- Seoul
- State
- KR-11
- Postal Code
- 08594
- Country
- KR
- Correspondent
- Johnny Jung
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 |
|---|---|---|---|---|---|
| Solid State X-Ray Imager (Flat Panel/Digital Imager) | MQB | Class 2 | Radiology | No | 2022-03-31 |
| System, Image Processing, Radiological | LLZ | Class 2 | Radiology | No | 2023-08-09 |
| System, X-Ray, Extraoral Source, Digital | MUH | Class 2 | Dental | No | 2021-06-21 |
Proprietary Names
Focus HD 43
Focus HD 35
TRIMAX 35C
Focus 35C
Mars1417X Wireless Digital Flat Panel Detector
AcuityDR 1717 G4
AcuityDR 1013 G4
AcuityDR 1417 G4
A17 Mars1417V-PSI
A17 Mars1417V-TSI
Focus 43C
TRIMAX 43C
DR17W
Mano4343W
Mars1717V-VSI(V3)
Venu1717X
DR17T
Mano4343X
Mano4343T
Pluto0002X
Pluto0001X
Lux HD 35/43
Mars1717X Wireless Digital Flat Panel Detector
DR14W
Mano4336W
Mars1417V-TSI(V3)
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)