Skip to content

Medical Infrared Thermometer (Model: RST-TC59-1001, RST-TC60-1001)

by Zhejiang Rongsheng Industrial Co., Ltd.

510(k) K220657

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) K220657↗

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 NumberK220657 Date10 Feb 2023ClearedStatusActive
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  • Withdrawn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 Medical Infrared Thermometer (Models RST-TC59-1001, RST-TC60-1001) is a continuous measurement thermometer designed for non-contact temperature assessment. It utilises infrared technology to measure body temperature without physical contact, ensuring rapid and hygienic readings in clinical settings.

These devices are intended for single-use or reusable applications in general hospital environments, adhering to FDA 510(k) clearance (K220657) and MDR authorisations. Supplied sterile or non-sterile as specified, they comply with regulatory standards under 21 CFR 880.2910 and are classified under product code FLL as Class II devices. Storage and handling follow manufacturer guidelines to maintain accuracy and performance.

Other devices from Zhejiang Rongsheng Industrial Co., Ltd.