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NIPRO CORPORATION

Japan JP-MF-000026759 Last updated 23 Oct 2026

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Devices
22
Registries
EUDAMEDFDA
FDA recalls
0

Catalogue22

  • Dental Needle Ref 7712

    Class IIa EUDAMED Active

  • Curacase Ref ZT002-009-0001-015

    Class IIa EUDAMED Active

  • Elisio Ref ELI-19H-GC

    Class IIb EUDAMED Active

  • Sureflux Ref SF-11E-GJ

    Class IIb EUDAMED Active

  • Sureflux Ref SF-11UX-PO-GJ

    Class IIb EUDAMED Active

  • Solacea Ref SLC-17H-GJ

    Class IIb EUDAMED Active

  • Sureflux Ref SF-13N-GJ

    Class IIb EUDAMED Active

  • Fb Ref FB 15U-GJ

    Class IIb EUDAMED Active

  • Sureflux Ref SF-05L-PO-GJ

    Class IIb EUDAMED Active

  • Elisio Ref ELI-21L-GJ

    Class IIb EUDAMED Active

  • Elisio Ref ELI-19L-PO-GJ

    Class IIb EUDAMED Active

  • Elisio Ref ELI-15L-PO-GJ

    Class IIb EUDAMED Active

  • Elisio Ref ELI-19M-GJ

    Class IIb EUDAMED Active

  • Elisio Ref ELI-21H-PO-GC

    Class IIb EUDAMED Active

  • Elisio Ref ELI-15H-GJ

    Class IIb EUDAMED Active

  • Sureflux Ref SF-13UX-GJ

    Class IIb EUDAMED Active

  • Sureflux Ref SF-15L-GJ

    Class IIb EUDAMED Active

  • Sureflux Ref SF-11E-PO-GJ

    Class IIb EUDAMED Active

  • Sureflux Ref SF-09L-GJ

    Class IIb EUDAMED Active

  • Fb Ref FB 21U-GJ

    Class IIb EUDAMED Active

  • Sureflux Ref SF-15E-GJ

    Class IIb EUDAMED Active

  • Sureflux Ref SF-03L-GJ

    Class IIb EUDAMED Active

Related companies

Authorised representatives

FDA establishments1

Registered with the FDA under this company group, matched by name.

  • Nipro Company, Ltd. JP

What NIPRO CORPORATION makes

Nipro Corporation manufactures medical devices including infusion pumps (SUREFLUX), hemodialysis systems (SOLACEA), vascular access needles (VMK ENDONEEDLE), and blood filtration systems (FB). Their portfolio also includes insulin infusion devices (ELISIO) and related consumables for patient monitoring and treatment.

The company’s devices are classified under EU regulations as Class I, Class IIa, and Class IIb, with listings recorded in the EU’s eudamed registry. Nipro Corporation is headquartered in Japan.

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

Frequently asked questions

What types of medical devices does Nipro Corporation manufacture?

Nipro Corporation produces a range of medical devices, including infusion pumps (like SUREFLUX), hemodialysis systems (such as SOLACEA), vascular access needles (VMK ENDONEEDLE), and blood filtration systems (FB). Their portfolio also covers insulin infusion devices (ELISIO) and associated consumables for patient monitoring and treatment. These devices are designed to support infusion therapy, dialysis, and vascular access needs.

Where is Nipro Corporation based?

Nipro Corporation is headquartered in Japan. The company’s global operations and regulatory presence are centered around this location, though its devices are distributed internationally for use in various healthcare settings.

Which regulatory registries list Nipro Corporation’s devices?

Nipro Corporation’s devices are listed in the eudamed registry, which is the official EU database for medical devices. This registry tracks manufacturers, devices, and their classifications under EU regulations, ensuring transparency for healthcare professionals and regulatory authorities.

How are Nipro Corporation’s devices classified under EU regulations?

Nipro Corporation’s devices fall under Class I, Class IIa, and Class IIb classifications in the EU. These classifications determine the level of regulatory scrutiny and risk associated with the device, with Class IIb indicating a higher risk requiring additional safety measures and documentation.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
Japan
Address
3-26, Senriokashinmachi, Settsu, Osaka, Japan
Website
nipro.co.jp
PRRC contact
Toyoshi YOSHIDA
EUDAMED SRN
JP-MF-000026759
FDA FEI number
3000247873