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Nipro Company, Ltd.

Japan JP-MF-000026759 Last updated 22 Oct 2026 Part of Nipro Corporation

Devices
163
Registries
EUDAMED
FDA recalls
1

Catalogue163

Page 1 of 4

  • Dental Needle Ref 7710

    Class IIa EUDAMED Active

  • Curacase Ref ZT002-009-0001-020

    Class IIa EUDAMED Active

  • Curacase Ref ZT002-009-0001-006

    Class IIa EUDAMED Active

  • Curacase Ref ZT002-009-0001-016

    Class IIa EUDAMED Active

  • Curacase Ref ZT002-009-0001-003

    Class IIa EUDAMED Active

  • Curacase Ref ZT002-009-0001-030

    Class IIa EUDAMED Active

  • Dental Needle Ref 7716

    Class IIa EUDAMED Active

  • Curacase Ref ZT002-009-0001-014

    Class IIa EUDAMED Active

  • Surdial X Ref Type C 230V

    Class IIb EUDAMED Active

  • Curacase Ref ZT002-009-0001-005

    Class IIa EUDAMED Active

  • Surdial X Ref Type D 230V

    Class IIb EUDAMED Active

  • Curacase Ref ZT002-009-0001-001

    Class IIa EUDAMED Active

  • Curacase Ref ZT002-009-0001-021

    Class IIa EUDAMED Active

  • Dental Needle Ref 7711-100

    Class IIa EUDAMED Active

  • Curacase Ref ZT002-009-0001-009

    Class IIa EUDAMED Active

  • Curacase Ref ZT002-009-0001-013

    Class IIa EUDAMED Active

  • Curacase Ref ZT002-009-0001-022

    Class IIa EUDAMED Active

  • Curacase Ref ZT002-009-0001-011

    Class IIa EUDAMED Active

  • Dental Needle Ref 7717-100

    Class IIa EUDAMED Active

  • Surdial X Ref Type A 230V

    Class IIb EUDAMED Active

  • Dental Needle Ref 7713

    Class IIa EUDAMED Active

  • Curacase Ref ZT002-009-0001-023

    Class IIa EUDAMED Active

  • Surdial X Ref Type B 230V

    Class IIb EUDAMED Active

  • Curacase Ref ZT002-009-0001-017

    Class IIa EUDAMED Active

  • Dental Needle Ref 7711

    Class IIa EUDAMED Active

  • Dental Needle Ref 7717

    Class IIa EUDAMED Active

  • Curacase Ref ZT002-009-0001-018

    Class IIa EUDAMED Active

  • SURDIAL 55Plus Ref SURDIAL 55Plus

    Class IIb EUDAMED Active

  • Curacase Ref ZT002-009-0001-028

    Class IIa EUDAMED Active

  • Curacase Ref ZT002-009-0001-008

    Class IIa EUDAMED Active

  • Curacase Ref ZT002-009-0001-025

    Class IIa EUDAMED Active

  • Curacase Ref ZT002-009-0001-012

    Class IIa EUDAMED Active

  • Elisio Ref ELI-15H-GC

    Class IIb EUDAMED Active

  • Elisio Ref ELI-19L-GJ

    Class IIb EUDAMED Active

  • Pressone Ref ZT002-009-0001-007

    Class IIa EUDAMED Active

  • Elisio Ref ELI-21M-PO-GJ

    Class IIb EUDAMED Active

  • Curacase Ref ZT002-009-0001-027

    Class IIa EUDAMED Active

  • Curacase Ref ZT002-009-0001-024

    Class IIa EUDAMED Active

  • Curacase Ref ZT002-009-0001-004

    Class IIa EUDAMED Active

  • Elisio Ref ELI-09HX-GJ

    Class IIb EUDAMED Active

  • Curacase Ref ZT002-009-0001-002

    Class IIa EUDAMED Active

  • Elisio Ref ELI-17H-PO-GJ

    Class IIb EUDAMED Active

  • Curacase Ref ZT002-009-0001-010

    Class IIa EUDAMED Active

  • Curacase Ref ZT002-009-0001-026

    Class IIa EUDAMED Active

  • Curacase Ref ZT002-009-0001-029

    Class IIa EUDAMED Active

  • Elisio Ref ELI-25HX-GJ

    Class IIb EUDAMED Active

  • Fb Ref FB 13U-GJ

    Class IIb EUDAMED Active

  • Curacase Ref ZT002-009-0001-019

    Class IIa EUDAMED Active

  • Elisio Ref ELI-19H-GC

    Class IIb EUDAMED Active

  • Sureflux Ref SF-05L-GJ

    Class IIb EUDAMED Active

Showing 1-50 of 163

FDA recalls1

Recalls this firm reported to the FDA. Device pages show the recalls that name the device or the 510(k)/PMA it was cleared under.

Nipro Company, Ltd. has one FDA recall record initiated on 2002-11-08, which is marked as terminated. The recall was due to the potential for air or fluid leakage at the hub/needle junction.

AI-generated summary of the recall 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.

Frequently asked questions

What types of medical devices does Nipro Company, Ltd. manufacture?

Nipro Company, Ltd. specializes in bedside medical consoles and intravenous infusion pumps. For example, they produce the HA-57P bedside console, which integrates monitoring and control functions, as well as the BIP-BH blood and heparin pump. These devices are designed for hospital environments to administer fluids and medications safely at the patient’s bedside.

Where is Nipro Company, Ltd. based, and where are their devices primarily used?

Nipro Company, Ltd. is based in the United States. Their devices, including infusion pumps and bedside consoles, are intended for use in U.S. healthcare settings, where they must meet FDA regulatory requirements for safety and performance.

How are Nipro Company, Ltd.’s devices classified by the FDA, and what pathway is used for their authorization?

Nipro Company, Ltd.’s devices, such as the HA-57P bedside console and BIP-BH blood pump, fall under FDA Class II regulatory classification. This classification applies to devices that pose moderate risk and require special controls to ensure their safety and effectiveness. The company’s devices are authorized through the FDA’s 510(k) clearance pathway, which demonstrates substantial equivalence to a legally marketed predicate device.

Which regulatory registries or databases list Nipro Company, Ltd.’s medical devices?

Nipro Company, Ltd.’s devices are listed in the FDA’s 510(k) clearance database. This registry confirms that their products, including infusion pumps and bedside consoles, have undergone the required review process to demonstrate compliance with FDA regulations for Class II devices.

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