FDA Registration
Active
🇯🇵 Japan
SHINO-TEST CORPORATION
Reg #: 3012240236
·
FEI: 3012240236
·
Expires 2026
Products
3
Proprietary Names
4
Establishment Types
1
Classifications
3
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Registration Details
- Registration Name
- SHINO-TEST CORPORATION
- Registration Number
- 3012240236
- FEI Number
- 3012240236
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 4-1-93 Oonodai, Minami-ku
- City
- Sagamihara Kanagawa
- Country
- JP
Owner / Operator
- Firm Name
- SHINO-TEST CORPORATION
- Operator Number
- 10092089
- Address
- 3-7-9 Kanda-Surugadai
- City
- Chiyoda-ku
- State
- Tokyo
- Postal Code
- 101-8410
- Country
- JP
- Correspondent
- Isoko Hirase
US Agent
- Business Name
- Medical Device Compliance Support LLC
- Contact Name
- Isoko Hirase
- Address
- 1159 Thomas Randolph Place
- City
- Lynchburg
- State
- VA
- ZIP
- 24503
- Country
- US
- [email protected]
- Phone
- 469 3631224
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Enzyme Controls (Assayed And Unassayed) | JJT | Class 1 | Clinical Chemistry | No | 2024-12-03 |
| Lipase-Esterase, Enzymatic, Photometric, Lipase | CHI | Class 1 | Clinical Chemistry | No | 2024-12-03 |
| Calibrator, Secondary | JIT | Class 2 | Clinical Chemistry | No | 2024-12-03 |
Proprietary Names
LIP Control
LIP Control (H)
Cygnus Auto LIP
LIP Serum Calibrator
Establishment Types
Manufacture Medical Device