FDA Registration
Active
🇺🇸 United States
NIPRO MEDICAL CORPORATION
Reg #: 1056186
·
FEI: 1000132332
·
Expires 2026
Products
12
Proprietary Names
19
Establishment Types
1
Classifications
12
Registration Details
- Registration Name
- NIPRO MEDICAL CORPORATION
- Registration Number
- 1056186
- FEI Number
- 1000132332
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 3150 NW 107TH AVE
- City
- Doral
- State
- FL
- ZIP
- 33172
- Country
- US
Regulatory Submissions
- 510(k) Number
- K131641
Owner / Operator
- Firm Name
- NIPRO CORPORATION
- Operator Number
- 8030375
- Address
- 3-26, Senriokashinmachi
- City
- Settsu
- State
- Osaka
- Postal Code
- 566-8510
- Country
- JP
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Syringe, Piston | FMF | Class 2 | General Hospital | No | 2013-11-12 |
| Dialysate Concentrate For Hemodialysis (Liquid Or Powder) | KPO | Class 2 | Gastroenterology, Urology | No | 2026-02-02 |
| Needle, Fistula | FIE | Class 2 | Gastroenterology, Urology | No | 2010-04-13 |
| Set, Tubing, Blood, With And Without Anti-Regurgitation Valve | FJK | Class 2 | Gastroenterology, Urology | No | 2012-11-22 |
| Set, Administration, Intravascular | FPA | Class 2 | General Hospital | No | 2012-11-20 |
| Dialyzer, High Permeability With Or Without Sealed Dialysate System | KDI | Class 2 | Gastroenterology, Urology | No | 2017-03-21 |
| Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | FOZ | Class 2 | General Hospital | No | 2007-11-15 |
| Needle, Hypodermic, Single Lumen | FMI | Class 2 | General Hospital | No | 2012-11-20 |
| Catheter, Hemodialysis, Non-Implanted | MPB | Class 2 | Gastroenterology, Urology | No | 2007-11-15 |
| Accessories, Blood Circuit, Hemodialysis | KOC | Class 2 | Gastroenterology, Urology | No | 2007-11-15 |
| System, Blood, Extracorporeal And Accessories | LLB | Class 2 | Gastroenterology, Urology | No | 2007-11-15 |
| Protector, Transducer, Dialysis | FIB | Class 2 | Gastroenterology, Urology | No | 2008-03-31 |
Proprietary Names
Nipro
NIPRO BioHole Needle with CAPICK
Scab Remover
Nipro Set - SLIMLINE Blood Tubing Set with Transducer Protector and Priming Set
Nipro SafeTouch II Gamma
NIPRO Cellentia Dialyzer
Nipro SafeTouch II Safety AVF
ELISIO-09H and 25H.
ELISIO-11H, 13H, 15H, 17H, 19H and 21H. ELISIO-11M, 13M, 15M, 17M, 19M and 21M.
Nipro Scalp Vein Set
Nipro SafeTouch TULIP Safety AVF
Nipro Syringe
NIPRO SAFELET CATH
NIPRO Transducer Protector TP-SURE
Nipro SafeTouch Needle; Nipro Syringe with SafeTouch Needle
Nipro blood tubing set
Nipro Set - Blood Tubing Set with Transducer Protector and Priming Set
Surdial DX Hemodialysis System and Accessories
Nipro SafeTouch Safety BCS
Establishment Types
Complaint File Establishment per 21 CFR 820.198