Skip to content

YUWELL Infrared Thermometer

by Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.

510(k) K201864

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) K201864↗

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 NumberK201864 Date7 Dec 2020ClearedStatusActive
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  • Withdrawn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
FLL
Device Class
Class II
Regulation
21 CFR Part 880.2910
Advisory Committee
General Hospital
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 YUWELL Infrared Thermometer is a non-contact infrared thermometer classified under the product code FLL. It is designed for measuring body temperature without physical contact, enabling rapid and hygienic assessments suitable for patients of all ages.

This device is supplied as a single-use or reusable medical instrument, depending on the model variant, and is intended for use in general hospital settings. It adheres to FDA 510(k) clearance and MDR compliance standards, ensuring regulatory alignment for clinical applications. The device is manufactured in Danyang, Jiangsu, China, and includes a model-specific reference code for identification.

Other devices from Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.

See all devices from Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. →