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Reusable NIBP Cuff

by Shenzhen Coreray Technology Co., Ltd.

510(k) K211747

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K211747↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK211747 Date23 Sep 2021ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
DXQ
Device Class
Class II
Regulation
21 CFR Part 870.1120
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Reusable NIBP Cuff is a non-invasive blood pressure measurement device component classified as a Blood Pressure Monitor Cuff (FDA Product Code: DXQ). It is designed to inflate and deflate around the upper arm or wrist to measure systolic and diastolic blood pressure via oscillometric principles, providing continuous or intermittent readings for clinical monitoring.

This cuff is intended for reusable clinical use and must be cleaned and disinfected between patients to maintain sterility. Supplied as a standalone component, it is compatible with oscillometric blood pressure monitors and adheres to FDA 510(k) clearance (K211747) and EU MDR requirements. Sizes are standardized for adult and pediatric use, with storage instructions specifying protection from direct sunlight and extreme temperatures.

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