FDA Registration
Active
🇯🇵 Japan
REXXAM.CO., LTD.
Reg #: 3009132348
·
FEI: 3009132348
·
Expires 2026
Products
9
Proprietary Names
24
Establishment Types
3
Classifications
9
Registration Details
- Registration Name
- REXXAM.CO., LTD.
- Registration Number
- 3009132348
- FEI Number
- 3009132348
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 958 Ikeuchi, Konan-cho
- City
- Takamatsu Kagawa
- Country
- JP
Owner / Operator
- Firm Name
- Rexxam.Co., Ltd.
- Operator Number
- 10034243
- Address
- 958 Ikeuchi, Konan-cho
- City
- Takamatsu
- State
- Kagawa
- Postal Code
- 761-1494
- Country
- JP
- Correspondent
- Yoshihiro Kikuchi
US Agent
- Business Name
- Emergo Global Representation LLC
- Contact Name
- Yong Sun
- Address
- 2500 Bee Cave Rd., Bldg. 1, Ste. 300
- City
- Austin
- State
- TX
- ZIP
- 78746
- Country
- US
- [email protected]
- Phone
- 512 3279997
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Refractometer, Ophthalmic | HKO | Class 1 | Ophthalmic | No | 2010-11-17 |
| Chart, Visual Acuity | HOX | Class 1 | Ophthalmic | No | 2017-09-18 |
| Projector, Ophthalmic | HOS | Class 1 | Ophthalmic | No | 2017-10-13 |
| Pupillometer, Manual | HLH | Class 1 | Ophthalmic | No | 2017-10-13 |
| Refractor, Manual, Non-Powered, Including Phoropter | HKN | Class 1 | Ophthalmic | No | 2010-11-17 |
| Set, Lens, Trial, Ophthalmic | HPC | Class 1 | Ophthalmic | No | 2018-09-20 |
| Instrument, Measuring, Lens, Ac-Powered | HLM | Class 1 | Ophthalmic | No | 2011-01-19 |
| Frame, Trial, Ophthalmic | HPA | Class 1 | Ophthalmic | No | 2017-10-13 |
| Tester, Color Vision | HIT | Class 1 | Ophthalmic | No | 2019-10-22 |
Proprietary Names
OptoChek Plus
RET-700
ACCUREF R800
ACCUREF K900
WAM-5500
N Vision-K5001
LCD-1000
LCD-1000P
CP-500
PDM DIGITAL PD METER
PD-82II
SightChek
DR-900
TL-34P
TL-35M
DL-2000 E
DL-2000 S
LensChek Plus
ML1
LensChek Pro
LM-25D
DL-2000 P
TF-3
ISHIHARA
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device
Export Device to the United States But Perform No Other Operation on Device