FDA Registration
Active
🇺🇸 United States
MedicaLyte
Reg #: 1528807
·
FEI: 1000142899
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Nipro Renal Solutions USA, Corporation
- Registration Number
- 1528807
- FEI Number
- 1000142899
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 509 Fishing Creek Rd
- City
- LEWISBERRY
- State
- PA
- ZIP
- 17339
- Country
- US
Regulatory Submissions
- 510(k) Number
- K131202
Owner / Operator
- Firm Name
- Nipro Renal Solutions USA, Corp
- Operator Number
- 10035998
- Address
- 509 Fishing Creek Road
- City
- Lewisberry
- State
- PA
- Postal Code
- 17339
- Country
- US
- Correspondent
- Jessica Oswald-McLeod
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Dialysate Concentrate For Hemodialysis (Liquid Or Powder) | KPO | Class 2 | Gastroenterology, Urology | No | 2014-06-03 |
Proprietary Names
MedicaLyte
Establishment Types
Manufacture Medical Device