FDA Registration
Active
🇰🇷 South Korea
GENORAY CO., LTD.
Reg #: 3005843418
·
FEI: 3005843418
·
Expires 2026
Products
7
Proprietary Names
42
Establishment Types
1
Classifications
7
Registration Details
- Registration Name
- GENORAY CO., LTD.
- Registration Number
- 3005843418
- FEI Number
- 3005843418
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 60, Dunchon-daero 541beon-gil, Jungwon-gu
- City
- Seongnam-si Gyeonggi
- Country
- KR
Regulatory Submissions
- 510(k) Number
- K220392
Owner / Operator
- Firm Name
- GENORAY CO., LTD.
- Operator Number
- 9093488
- Address
- 60, Dunchon-daero 541beon-gil, Jungwon-gu,, Seongnam-si, Gyeonggi, 13212, KOREA, SOUTH
- City
- SEONGNAM
- State
- KR-NOTA
- Postal Code
- 13212
- Country
- KR
US Agent
- Business Name
- Simon
- Contact Name
- Jo Suyoung
- Address
- 1220 N Simon Circle, Unit B
- City
- Anaheim
- State
- CA
- ZIP
- 92806
- Country
- US
- [email protected]
- Phone
- 822 4366729 ext. 236
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| X-Ray, Tomography, Computed, Dental | OAS | Class 2 | Radiology | No | 2022-05-19 |
| System, X-Ray, Fluoroscopic, Image-Intensified | JAA | Class 2 | Radiology | No | 2014-12-01 |
| Image-Intensified Fluoroscopic X-Ray System, Mobile | OXO | Class 2 | Radiology | No | 2014-12-01 |
| Interventional Fluoroscopic X-Ray System | OWB | Class 2 | Radiology | No | 2014-12-01 |
| System, X-Ray, Extraoral Source, Digital | MUH | Class 2 | Dental | No | 2025-11-18 |
| Full Field Digital, System, X-Ray, Mammographic | MUE | Class 2 | Radiology | No | 2025-07-21 |
| Unit, X-Ray, Extraoral With Timer | EHD | Class 2 | Dental | No | 2007-04-03 |
Proprietary Names
PAPAYA 3D Plus
PAPAYA 3D
ZEN-7000
GT300
GT300-C
PAPAYA Plus
PAPAYA
PortView
HESTIA
AREX
VETERA ACE
BELLIGER ACE
GenX-CR
ZEN-PX2
PORT-X II
OSCAR 15
ZEN-2090 Turbo
VETERA TURBO
VETERA PX
VETERA PE
ZEN-PX4 Vet
PORT-X Ive Vet
ZEN-PX4
PORT-X IV
ZEN-PX4e Vet
PORT-X IV Vet
PAPAYA 3D Premium Plus
PAPAYA 3D Premium
VETERA CLASSIC
VETERA PRIME
OSCAR Classic
OSCAR Prime
VETERA FD
OSCAR 15i
OPESCOPE ACTENO FD15
Unique FD
OSCAR 15FD
SC15
VETERA DM
VETERA DW
DVAS-M
DVAS-W
Establishment Types
Manufacture Medical Device