Health Canada Licensed MDL
Class II Medical Device
FDA Exempted Medical Device
Dual Mode Infrared Ear and Forehead Thermometer
Dual Mode Infrared Ear and Forehead Thermometer
Licensed by Health Canada as a Class II medical device (MDL 115591), issued in byTheia's own name. A reading from the forehead or the ear or the object in about one second.
- Forehead or Ear: switch to ear mode by taking off the probe cover
- About one second per reading, accurate to ±0.2 °C
- Colour-coded backlit display, Smart Fever Indicator: green, amber or red with every reading
- Adult, baby and object modes: check bottles, food and room surfaces too
- 35-reading memory, °C/°F switching and a silent mode for night checks
- Storage pouch and bilingual English/French manual included
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A medical thermometer, licensed like one
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Licensed in our name
Health Canada issued Medical Device Licence No. 115591 for this exact model, BTTM01, to the company behind byTheia. Search it on Health Canada's public MDALL database or see it on our certifications page.
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Ear or Forehead
Forehead for a quick check. Ear when you'd like to double-check. Take the probe cover off and it's ready for ear mode. Press setting button for 3 seconds, you can now measure room or object temperature.
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Smart fever indicator
The screen colour-codes every reading - green, amber or red and changes the beep pattern to match. You get the interpretation along with the number, in about a second.
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It remembers, so you don't have to
The last 35 readings are saved. When the doctor asks how the fever has tracked since Tuesday, you can show them instead of guessing.
How to take a temperature
Forehead, ear or object: which mode to use
| Forehead Mode | Ear Mode | Object Mode | |
|---|---|---|---|
| Best for | Quick checks, sleeping children, frequent re-checks | Double-checking a forehead reading | Bottles, food, bath water, room temperature |
| Measures | Body temperature; baby mode up to 36 months | Body temperature, 3 months and up | Surface temperature only — not people |
| Probe cover | On | Off | On or Off |
| For a good reading | Clean, dry forehead; no hair, sweat or makeup | Clean lens, snug fit, same ear each time | Hold 1–3 cm from the centre of the surface |
| Avoid when | Just in from the cold, after exercise or a bath | The ear is infected or has discharge | You need a body temperature -switch back to body mode first |
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Frequently Asked Questions
Yes. It holds Health Canada Medical Device Licence No. 115591 as a Class II device, issued for model BTTM01 to kobeswh.com Inc., the company behind byTheia. You can search the number in Health Canada's Medical Devices Active Licence Listing (MDALL) or view the licence on our certifications page.
No, and we'd rather say so than let a badge suggest otherwise. Infrared thermometers like this one are exempt from the FDA's 510(k) clearance process, so there's no clearance to claim. For a thermometer sold in Canada, the authorization that counts is the Health Canada licence. Note: Optional question, but it protects trust: your LED mask is FDA cleared, so customers may assume the thermometer is too.
Yes, in the right mode. Baby mode is for forehead readings on children up to 36 months, and ear mode is for children 3 months and older. For newborns, ask your healthcare provider which method they recommend.
Both modes are specified to ±0.2 °C. In everyday use, technique matters more: for an accurate forehead reading, the skin should be clean and dry; in the ear, the lens should be clean and the fit snug. Let everyone settle for about 30 minutes after coming in from outdoors. The two sites can read slightly differently, and so can left and right ears, so compare forehead with forehead and use the same ear each time.
Green means 32.0–37.3 °C, amber means 37.4–37.9 °C (elevated), and red means 38.0 °C or higher. Amber and red readings also flash and beep so you don't miss them.
Yes. Object mode reads surface temperature: hold the thermometer 1–3 cm from the bottle, food or surface and press to measure. It shows the temperature of the surface, not body temperature, so switch back to body mode before measuring a person.
Hi or Lo means the reading is outside the 32.0–42.9 °C body range, often because of a big temperature change or measuring the wrong spot. Er means the room is outside the 10–40 °C operating range. Let the thermometer sit in a normal room for about 30 minutes, then try again.
With the thermometer switched on, short-press the setting button to toggle between Celsius and Fahrenheit.
It runs on AAA batteries, and a set lasts about 3,000 readings. Removing the batteries clears the memory and resets your settings.
One year from the date of purchase, including thermometers bought on Amazon: same device, same warranty. We ship free across Canada from Markham, Ontario.