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Nipro Company, Ltd.

Japan Last updated 22 Oct 2026 Part of Nipro Corporation

Devices
163
Registries
EUDAMEDFDA 510(k)
FDA recalls
1

Catalogue163

Page 2 of 4

  • Sureflux Ref SF-11N-GJ

    Class IIb EUDAMED Active

  • Solacea Ref SLC-21H-GJ

    Class IIb EUDAMED Active

  • Sureflux Ref SF-11E-GJ

    Class IIb EUDAMED Active

  • Sureflux Ref SF-11UX-PO-GJ

    Class IIb EUDAMED Active

  • Sureflux Ref SF-21UX-GJ

    Class IIb EUDAMED Active

  • Sureflux Ref SF-21UX-PO-GJ

    Class IIb EUDAMED Active

  • Sureflux Ref SF-25UX-GJ

    Class IIb EUDAMED Active

  • Solacea Ref SLC-17H-GJ

    Class IIb EUDAMED Active

  • Sureflux Ref SF-19E-GJ

    Class IIb EUDAMED Active

  • Vmk Endoneedle Ref EN-2825-ET

    Class I EUDAMED Active

  • Diacap Ref 7202215

    Class IIb EUDAMED Active

  • Diacap Ref 7202017

    Class IIb EUDAMED Active

  • Sureflux Ref SF-09E-PO-GJ

    Class IIb EUDAMED Active

  • Sureflux Ref SF-13N-GJ

    Class IIb EUDAMED Active

  • Solacea Ref SLC-15H-GJ

    Class IIb EUDAMED Active

  • Bedside Console Ha-57P/Blood & Heparin Pump Bip-Bh Ref K854479

    Class II FDA 510(k) Active

  • Fb Ref FB 15U-GJ

    Class IIb EUDAMED Active

  • Solacea Ref SLC-25H-GJ

    Class IIb EUDAMED Active

  • Elisio Ref ELI-19L-PO-GC

    Class IIb EUDAMED Active

  • Elisio Ref ELI-15HX-GJ

    Class IIb EUDAMED Active

  • Sureflux Ref SF-13E-PO-GJ

    Class IIb EUDAMED Active

  • Sureflux Ref SF-17UX-PO-GJ

    Class IIb EUDAMED Active

  • Sureflux Ref SF-05L-PO-GJ

    Class IIb EUDAMED Active

  • Sureflux Ref SF-19N-GJ

    Class IIb EUDAMED Active

  • Sureflux Ref SF-07L-PO-GJ

    Class IIb EUDAMED Active

  • Sureflux Ref SF-13E-GJ

    Class IIb EUDAMED Active

  • Sureflux Ref SF-17UX-GJ

    Class IIb EUDAMED Active

  • Safetouch Dialysis Cath Plus Ref AVSF-CATHP-1525-GJ

    Class IIa EUDAMED Active

  • Solacea Ref SLC-19H-GJ

    Class IIb EUDAMED Active

  • Sureflux Ref SF-17N-GJ

    Class IIb EUDAMED Active

  • Diacap Ref 7202019

    Class IIb EUDAMED Active

  • Sureflux Ref SF-19E-PO-GJ

    Class IIb EUDAMED Active

  • Sureflux Ref SF-13G-GJ

    Class IIb EUDAMED Active

  • Elisio Ref ELI-21L-GJ

    Class IIb EUDAMED Active

  • Sureflux Ref SF-19UX-PO-GJ

    Class IIb EUDAMED Active

  • Sureflux Ref SF-21E-PO-GJ

    Class IIb EUDAMED Active

  • Elisio Ref ELI-15L-GJ

    Class IIb EUDAMED Active

  • Elisio Ref ELI-19L-PO-GJ

    Class IIb EUDAMED Active

  • Safetouch Dialysis Cath Plus Ref AVSF-CATHP-1625-GJ

    Class IIa EUDAMED Active

  • Elisio Ref ELI-21L-PO-GJ

    Class IIb EUDAMED Active

  • Sureflux Ref SF-11G-GJ

    Class IIb EUDAMED Active

  • Sureflux Ref SF-21L-GJ

    Class IIb EUDAMED Active

  • Elisio Ref ELI-15L-PO-GJ

    Class IIb EUDAMED Active

  • Elisio Ref ELI-19M-GJ

    Class IIb EUDAMED Active

  • Sureflux Ref SF-09E-GJ

    Class IIb EUDAMED Active

  • Sureflux Ref SF-15UX-PO-GJ

    Class IIb EUDAMED Active

  • Diacap Ref 7202221

    Class IIb EUDAMED Active

  • Elisio Ref ELI-17H-GJ

    Class IIb EUDAMED Active

  • Elisio Ref ELI-11M-GJ

    Class IIb EUDAMED Active

  • Elisio Ref ELI-11K-GJ

    Class IIb EUDAMED Active

Showing 51-100 of 163

FDA recalls1

Device pages show only the recalls that name the device or its 510(k)/PMA.

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.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

  • 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.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Address
3-26, Senriokashinmachi, Settsu, Osaka, Japan
Website
nipro.co.jp
PRRC contact
Toyoshi YOSHIDA
EUDAMED SRN
JP-MF-000026759