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Nipro Company, Ltd.

Active in EUDAMED

Registered as NIPRO CORPORATION (NIPRO) in EUDAMED

Japanfrom SRN EUDAMED SRN JP-MF-000026759

Part of Nipro Corporation

Devices
163
Registrations
EUDAMED
FDA recalls
1

Catalogue163

Newest first, page 4 of 4

  • Fb Ref FB 19U-GJ

    Class IIb EUDAMED Active

  • Elisio Ref ELI-13L-PO-GC

    Class IIb EUDAMED Active

  • Elisio Ref ELI-19H-GJ

    Class IIb EUDAMED Active

  • Sureflux Ref SF-05E-GJ

    Class IIb EUDAMED Active

  • Sureflux Ref SF-13UX-PO-GJ

    Class IIb EUDAMED Active

  • Diacap Ref 7202219

    Class IIb EUDAMED Active

  • Elisio Ref ELI-17HX-GJ

    Class IIb EUDAMED Active

  • Fb Ref FB 07U-GJ

    Class IIb EUDAMED Active

  • Elisio Ref ELI-15M-PO-GJ

    Class IIb EUDAMED Active

  • Elisio Ref ELI-11HX-GJ

    Class IIb EUDAMED Active

  • Sureflux Ref SF-11L-GJ

    Class IIb EUDAMED Active

  • Diacap Ref 7202015

    Class IIb EUDAMED Active

  • Fb Ref FB 11U-GJ

    Class IIb EUDAMED Active

Showing 151-163 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
PRRC contact
Toyoshi YOSHIDA(public in EUDAMED)

FDA recalls1

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

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. Distribution: Nationwide and Canada Submission number: K002813

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.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.