FDA Registration
Active
🇯🇵 Japan
SillHa paper Test Strip Kit
Reg #: 9611444
·
FEI: 3002807423
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ARKRAY, INC.
- Registration Number
- 9611444
- FEI Number
- 3002807423
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Yousuien-nai, 59 Gansuin-cho,
- City
- Kamigyo-ku Kyoto
- Country
- JP
Owner / Operator
- Firm Name
- ARKRAY, INC.
- Operator Number
- 8030316
- Address
- 8260 NW 27th Street, Suite 403
- City
- Miami
- State
- FL
- Postal Code
- 33122
- Country
- US
US Agent
- Business Name
- ARKRAY Factory USA, Inc.
- Contact Name
- Tom Speikers
- Address
- 8260 NW 27th Street, Suite 403
- City
- Miami
- State
- FL
- ZIP
- 33122
- Country
- US
- [email protected]
- Phone
- 952 6463168
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | LXG | Class 1 | Clinical Chemistry | No | 2018-04-27 |
Proprietary Names
SillHa paper Test Strip Kit
SillHa LH-4912 Oral Wellness System
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility