Company profile

About Nipro

A lean fact sheet for procurement, laboratory quality, and biomedical engineering teams evaluating Nipro in-vitro diagnostics and laboratory equipment. Confirm current registrations, certificates, and market labeling by product reference—never assume a single letter covers every country.

Focus: In-vitro diagnostics & laboratory equipment for hospital and reference labs
Buyer context: Hospital labs, reference labs, specialty clinics, and value analysis committees
Quality lens: ISO 13485 QMS scope review with site-specific certificate checks
Risk method: ISO 14971 risk-benefit analysis tied to intended use
IVD path (EU): CE mark under IVDR 2017/746 by reference and DoC revision
US path: FDA 510(k) cleared status by reference—not “FDA approved” for 510(k) devices
Software: IEC 62304 lifecycle evidence where software is a medical device component
Identity: UDI labeling and lot/expiry traceability for recall readiness
Service stance: Installation, IQ/OQ/PQ, PM, and field repair planning with MTTR bands
Documentation: IFU, DHF/DMR, and PMS outline via Spec Library controlled request

Certification checklist (request by reference)

FDA 510(k) substantial equivalence summary — when the marketed reference is cleared
CE IVDR technical documentation and Declaration of Conformity
ISO 13485 certificate with current scope and sites
ISO 14971 risk management file excerpts relevant to intended use
IEC 62304 software classification and release notes for connected analyzers
Post-market surveillance (PMS) and complaint handling process outline

Need a controlled document package?

Use Contact to request IFU, specifications, or quality certificates for a named product reference.

Contact Nipro