FDA Registration
Active
🇯🇵 Japan
NIPRO MEDICAL INDUSTRIES LTD.
Reg #: 9611446
·
FEI: 3002807725
·
Expires 2026
Products
9
Proprietary Names
8
Establishment Types
2
Classifications
9
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Registration Details
- Registration Name
- NIPRO MEDICAL INDUSTRIES LTD.
- Registration Number
- 9611446
- FEI Number
- 3002807725
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 2-19-64, MATSUBARA
- City
- TATEBAYASHI-SHI Gunma
- Country
- JP
Regulatory Submissions
- 510(k) Number
- K001251
Owner / Operator
- Firm Name
- NIPRO CORPORATION
- Operator Number
- 8030375
- Address
- 3-26, Senriokashinmachi
- City
- Settsu
- State
- Osaka
- Postal Code
- 566-8510
- Country
- JP
- Correspondent
- Nobuhiro Morimoto
US Agent
- Business Name
- NIPRO MEDICAL CORPORATION
- Contact Name
- JESSICA OSWALD-MCLEOD
- Address
- 3150 NW 107th Ave
- City
- Doral
- State
- FL
- ZIP
- 33172
- Country
- US
- [email protected]
- Phone
- 305 4326699
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Needle, Dental | DZM | Class 1 | Dental | No | 2006-07-12 |
| Needle, Hypodermic, Single Lumen | FMI | Class 2 | General Hospital | No | 2007-12-27 |
| Wire, Guide, Catheter | DQX | Class 2 | Cardiovascular | No | 2007-11-20 |
| Tubes, Vials, Systems, Serum Separators, Blood Collection | JKA | Class 2 | Clinical Chemistry | No | 2008-01-08 |
| Needle, Ophthalmic Suturing | HNM | Class 1 | Ophthalmic | No | 2017-05-31 |
| Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | FOZ | Class 2 | General Hospital | No | 2014-09-08 |
| System, Blood Collection, Vacuum-Assisted, Manual | KST | Class 1 | Hematology | No | 2008-06-01 |
| Container, Specimen, Sterile | FMH | Class 1 | Pathology | No | 2008-02-19 |
| Needle, Aspiration And Injection, Disposable | GAA | Class 1 | General, Plastic Surgery | No | 2004-04-16 |
Proprietary Names
Dental Needle
Sniper Hydrophilic Guidewire
AQUALiner
Ophthalmic Needle
Safe Touch PSV Winged Infusion Set (with or without filter)
Nipro Blood Collection Needle
PRESSONE
Needle
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)