Non Contact Infrared Body Thermometer
3 catalogue numbers from HTD8816C, listed by Hetaida Technology Co., Ltd., China, under Continuous Measurement Thermometer. 115 manufacturers in China are registered for this product code.
115manufacturers in China registered for this device type
3catalogue numbers in this listing
5510(k) clearances naming this product code
Who Else Makes It
Concentrated in Guangdong (68), Zhejiang (15), Jiangsu (13). 17 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
| Well Lead Medical Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 46 |
| Zhejiang Hongyu Medical Commodity Co., Ltd. | Yiwu | Zhejiang | Contract manufacturer | 36 |
| Hochuen Medical Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 20 |
| Jiangyin Sinbon Electronics Co Ltd | Jiangyin | Jiangsu | Contract manufacturer | 13 |
| Tianjin Choice Medical Device Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 12 |
| Medwell Technology Limited | Dongguan | Guangdong | Contract manufacturer | 10 |
| Famidoc Technology Co., Ltd. | Dong Guan | Guangdong | Contract manufacturer | 9 |
| EMI (Dongguan) Asia Limited | Dongguan | Guangdong | Contract manufacturer | 9 |
| Tasco Medical Industries Co., Ltd. | Bao An District, Shenzhen | Guangdong | Contract manufacturer | 6 |
| Wuhan Strong Electronics | Wuhan | Hubei | Contract manufacturer | 6 |
| Betacera Inc. | Suzhou | Jiangsu | Contract manufacturer | 3 |
Showing 12 of 115. All 115 manufacturers in China registered for Continuous Measurement Thermometer
Record
| Listed by | Hetaida Technology Co., Ltd., China |
|---|---|
| FDA product code | FLL |
| Device type | Continuous Measurement Thermometer |
| Device class | Class 2 |
| Regulation | 21 CFR 880.2910 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| Record published | 2019-06-18 |
| Record revised | 2021-04-28 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Label carries | lot or batch number |
| Storage | Storage environment temperature -20 to 55 °C; Storage environment humidity 0 to 93 % RH; Storage environment atmospheric pressure 70 to 106 KiloPascal; Handling environment temperature 15 to 35 °C; Handling environment humidity 0 to 85 % RH; Handling environment atmospheric pressure 70 to 106 KiloPascal |
| Packaging | Pack of 40 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| HTD8816C | In distribution | |
| HTD8818A | In distribution | |
| HTD8808C | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Unimed | Unimed Medical Supplies Inc | 434 |
| Safety 1st | Dorel Juvenile Group, Inc. | 180 |
| Welch Allyn, Inc. | Welch Allyn, Inc. | 66 |
| Diagnostix™ | American Diagnostic Corp. | 61 |
| DeRoyal | Deroyal Industries, Inc. | 58 |
| Braun | KAZ USA, Inc. | 53 |
| Exergen Temporal Scanner | Exergen Corporation | 50 |
| Level 1 | ICU Medical, Inc | 48 |
| Famidoc | Famidoc Technology Co., Ltd. | 47 |
| Adtemp™ | American Diagnostic Corp. | 35 |
| TempTraq | Blue Spark Technologies, Inc. | 35 |
| Medline | Medline Industries, Inc. | 34 |
Showing 12 of 843. All products under Continuous Measurement Thermometer
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K203332 | 2021-02-25 |
| K200159 | 2021-01-05 |
| K180387 | 2019-01-10 |
| K171888 | 2018-07-23 |
| K180385 | 2018-05-11 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.