FDA Registration
Active
🇯🇵 Japan
UNISIS CORP
Reg #: 3020983482
·
FEI: 3020983482
·
Expires 2026
Products
3
Proprietary Names
3
Establishment Types
2
Classifications
3
Registration Details
- Registration Name
- UNISIS CORP
- Registration Number
- 3020983482
- FEI Number
- 3020983482
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1-2-8 Wattsu Industrial Complex
- City
- Kita-Hiroshima-shi Hokkaido
- Country
- JP
Regulatory Submissions
- 510(k) Number
- K172800
Owner / Operator
- Firm Name
- Unisis Corp
- Operator Number
- 10083347
- Address
- 1-2-8 Wattsu Industrial Complex
- City
- Kita-Hiroshima-shi
- State
- Hokkaido
- Postal Code
- 061-1281
- Country
- JP
US Agent
- Business Name
- Registrar Corp
- Contact Name
- David Lennarz
- Address
- 144 Research Drive
- City
- Hampton
- State
- VA
- ZIP
- 23666
- Country
- US
- [email protected]
- Phone
- 757 2240177
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Needle, Spinal, Short Term | MIA | Class 2 | Anesthesiology | No | 2024-12-26 |
| General Surgery Tray | LRO | Class 2 | General, Plastic Surgery | No | 2021-12-13 |
| Needle, Conduction, Anesthetic (W/Wo Introducer) | BSP | Class 2 | Anesthesiology | No | 2024-12-26 |
Proprietary Names
Uniever Disposable Nerve Blockade Needle
Uniever Disposable Epidural Anesthesia Needle
Uniever Disposable Spinal Anesthesia Needle
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)