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Infrared Thermometer Model E127

by Bioland Technology Ltd.

510(k) K201161

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) K201161↗

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 NumberK201161 Date2 Oct 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  • Withdrawn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
FDA applicant
Bioland Technology, Ltd.
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 Infrared Thermometer Model E127 is a non-contact temperature measurement device designed to measure surface and environmental temperatures using infrared radiation detection. It falls under the category of infrared thermometers, which are commonly used for rapid, contactless temperature assessment in clinical and non-clinical settings.

This device is supplied as a reusable instrument and is intended for use in general hospital environments. It requires no special sterility conditions but should be cleaned and maintained according to manufacturer guidelines. The Model E127 is authorised under FDA 510K clearance and MDR, with a product code of FLL. It is classified under the traditional clearance type and is not intended for MRI environments.

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Questions

AI-generated answers, 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.

  • Is the Infrared Thermometer Model E127 designed for single-use or reusable applications, and what maintenance is required?

    The Infrared Thermometer Model E127 is a reusable device intended for general hospital environments. While it does not require special sterility conditions, it must be cleaned and maintained according to the manufacturer’s guidelines to ensure accuracy and hygiene. Since it is not sterile out-of-the-box, routine disinfection between uses is recommended to prevent cross-contamination.

  • Can this device be used in environments where MRI machines are present, and if not, why?

    No, the Infrared Thermometer Model E127 is not intended for use in MRI environments. The device’s design and materials are not specified for compatibility with magnetic fields, which could interfere with its operation or pose safety risks in such settings. Always verify the manufacturer’s instructions for specific environmental restrictions.

  • What regulatory pathways has this device undergone, and what does that mean for its use in clinical settings?

    The Infrared Thermometer Model E127 has undergone FDA 510(k) clearance and MDR (Medical Device Regulation) authorization, confirming it meets regulatory standards for safety and performance. The product code FLL and traditional clearance type indicate it is classified under general hospital use, meaning it is approved for non-contact temperature measurement in clinical environments where surface or environmental temperatures are assessed.

  • How do I determine the correct model or size for my facility’s needs, given the specifications provided?

    The specifications for the Infrared Thermometer Model E127 do not list multiple sizes or models, implying it is a single unified device designed for general hospital use. However, if you require additional features (e.g., laser targeting, memory functions, or different measurement ranges), you may need to consult Bioland Technology Ltd. directly, as these details are not specified in the provided data. Always verify compatibility with your facility’s workflow before purchasing.