Infrared Thermometer E201
510(k) K213011
Active
Valid until
Not listed
FDA recalls
None foundTrust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK213011 | Date5 Apr 2022 | StatusActive |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Full name
- Infrared Thermometer (model: E201)
- 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
The Infrared Thermometer E201 is a non-contact temperature measurement device classified as an infrared thermometer. It utilises infrared radiation to measure surface temperatures without physical contact, providing rapid and precise readings for clinical and general use.
This device is intended for use in general hospital settings and is supplied as a reusable instrument. It is authorised under FDA 510K clearance and MDR compliance, with a product code of FLL. The thermometer is designed for single-use applications in temperature monitoring, ensuring accuracy and reliability in clinical environments.
Other devices from Bioland Technology Ltd.
Questions
AI-generated answers, 18 Sep 2026
Is the Infrared Thermometer E201 designed for repeated use in clinical settings, or is it meant to be discarded after a single use?
The Infrared Thermometer E201 is explicitly described as a reusable instrument, despite being authorised for single-use applications in temperature monitoring. This means it is intended to be cleaned and reused in clinical environments, provided proper sterilisation and maintenance protocols are followed. The manufacturer’s focus on reusable design aligns with its broader use in general hospital settings, where durability and repeated use are practical considerations.
How is the Infrared Thermometer E201 authorised for use in the United States and Europe, and what does this mean for buyers?
The device holds FDA 510K clearance (traditional route, K213011) and MDR compliance, confirming it meets regulatory standards for non-contact temperature measurement in both markets. The FDA’s Substantially Equivalent (SESE) decision under product code FLL (General Hospital) indicates it is deemed comparable to legally marketed predecessors, while MDR compliance ensures it aligns with EU safety and performance requirements. Buyers can rely on these authorisations for market access and clinical trust.
What types of environments is the Infrared Thermometer E201 intended for, and does its design accommodate specific clinical workflows?
The device is intended for general hospital settings, as indicated by its advisory committee classification (HO) and product code FLL. Its non-contact infrared technology enables rapid, contactless temperature readings, which is particularly useful in high-throughput or infection-control-sensitive areas like triage, pediatrics, or isolation units. The reusable design supports routine use in these environments, though buyers should ensure compliance with local sterilisation guidelines.
Are there multiple models or sizes available for the Infrared Thermometer E201, or is this a single-device offering?
The provided data specifies only one model (E201) of the Infrared Thermometer, with no mention of variants, sizes, or additional configurations. Buyers should confirm with Bioland Technology Ltd. if customisation (e.g., probe attachments, display options) is available, as the current description does not imply variability beyond the core E201 design for non-contact temperature measurement in clinical use.