Nipro Company, Ltd.
Active in EUDAMEDJapanfrom SRN EUDAMED SRN JP-MF-000026759
Part of Nipro Corporation
- Devices
- 163
- Registrations
- EUDAMED
- FDA recalls
- 1
Catalogue
Elisio Ref ELI-13H-PO-GJ
Elisio Ref ELI-21H-PO-GC
Elisio Ref ELI-21M-GC
Sureflux Ref SF-05N-GJ
Diacap Ref 7202021
Elisio Ref ELI-25H-PO-GJ
Sureflux Ref SF-13L-GJ
Sureflux Ref SF-09N-GJ
Sureflux Ref SF-21G-GJ
Elisio Ref ELI-19M-PO-GJ
Sureflux Ref SF-07E-GJ
Elisio Ref ELI-19M-GC
Sureflux Ref SF-07E-PO-GJ
Elisio Ref ELI-21M-GJ
Sureflux Ref SF-15UX-GJ
Sureflux Ref SF-17G-GJ
Elisio Ref ELI-15H-GJ
Sureflux Ref SF-13UX-GJ
Sureflux Ref SF-07L-GJ
Sureflux Ref SF-15L-GJ
Elisio Ref ELI-15M-PO-GC
Sureflux Ref SF-11E-PO-GJ
Sureflux Ref SF-19G-GJ
Elisio Ref ELI-13H-PO-GC
Fb Ref FB 09U-GJ
Sureflux Ref SF-03L-PO-GJ
Sureflux Ref SF-17L-GJ
Sureflux Ref SF-19L-GJ
Elisio Ref ELI-13K-GJ
Sureflux Ref SF-17E-GJ
Sureflux Ref SF-21E-GJ
Sureflux Ref SF-19UX-GJ
Diacap Ref 7202217
Elisio Ref ELI-09H-GJ
Sureflux Ref SF-15N-GJ
Safetouch Dialysis Cath Plus Ref AVSF-CATHP-1538-GJ
Sureflux Ref SF-21N-GJ
Sureflux Ref SF-25UX-PO-GJ
Sureflux Ref SF-09L-GJ
Sureflux Ref SF-15G-GJ
Sureflux Ref SF-09L-PO-GJ
Fb Ref FB 05U-GJ
Fb Ref FB 17U-GJ
Elisio Ref ELI-15L-GC
Sureflux Ref SF-15E-PO-GJ
Sureflux Ref SF-11UX-GJ
Sureflux Ref SF-15E-GJ
Elisio Ref ELI-11L-GJ
Sureflux Ref SF-07N-GJ
Sureflux Ref SF-03L-GJ
Showing 101-150 of 163
Company details
- EUDAMED SRN
- JP-MF-000026759
- EUDAMED status
- Active
- EUDAMED registered name
- NIPRO CORPORATION
- EUDAMED abbreviated name
- NIPRO
- Registered address
- 3-26, Senriokashinmachi, Settsu, 566-8510, Osaka, Japan
- [email protected]
- PRRC contact
- Toyoshi YOSHIDA
FDA recalls
FDA recall records list 1 recall initiated by Nipro Company, Ltd., initiated on 2002-11-08. By recorded status: 1 terminated. The reasons filed fall into these groups: mechanical integrity. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2002
- 8 Nov 2002 Z-0408-03 Unclassified (pre-2012) Terminated Air or fluid leakage at the hub/needle junction.
What Nipro Company, Ltd. makes
Nipro Company, Ltd. manufactures bedside medical consoles, including the HA-57P model, and intravenous infusion pumps such as the BIP-BH blood and heparin pump. These devices are designed for hospital use to administer fluids and medications while providing integrated monitoring and control functions at the patient’s bedside.
The company’s products fall under FDA Class II regulatory classification and are listed via the 510(k) clearance pathway. These devices are intended for use in the United States, where they must comply with applicable FDA requirements for safety and performance.