Medline
Thermometer, Talking, EAR/Forehead, Home
115manufacturers in China registered for this device type
34catalogue numbers in this listing
3510(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 | Medline Industries, Inc., United States |
|---|---|
| FDA product code | FLL |
| Device type | Continuous Measurement Thermometer |
| Device class | Class 2 |
| Regulation | 21 CFR 880.2910 |
| 510(k) | K152508 |
| Record published | 2016-10-14 |
| Record revised | 2023-02-06 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Over the counter | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Handling environment atmospheric pressure 70 to 106 KiloPascal; Storage environment temperature -25 to 55 °C; Handling environment temperature 15 to 40 °C; Handling environment humidity 15 to 95 % RH; Storage environment humidity 15 to 95 % RH |
| Packaging | Box of 12, case of 200, box of 10, box of 50, case of 50, mc of 40 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| DYNJASK400SK | In distribution | ||
| MDS9700 | In distribution | ||
| MDSBT17THERM | In distribution | ||
| MDS9608 | 100 | In distribution | |
| MDS99901 | In distribution | ||
| MDS9700 | In distribution | ||
| MDS9953 | In distribution | ||
| MDSTH1002 | In distribution | ||
| DYNJAAC400MPM | In distribution | ||
| MDS201550Z | In distribution | ||
| MDS9656 | In distribution | ||
| MDS9952 | In distribution | ||
| DYNJAA400TY | In distribution | ||
| MDS9950 | In distribution | ||
| MDS9655 | In distribution | ||
| MDS99902UVP | In distribution | ||
| MDSNOTOUCH | In distribution | ||
| MDSM3A7208058 | 200 | In distribution | |
| MDS7701 | 25 | In distribution | |
| MDS9607 | 100 | In distribution | |
| MDS9620SVM | In distribution | ||
| MDS9929 | In distribution | ||
| DYNJAAC400PM | In distribution | ||
| MDS9701 | In distribution | ||
| MDS201519Z | In distribution | ||
| MDS9928 | In distribution | ||
| MDSVSMN1 | In distribution | ||
| SHNOTOUCH | In distribution | ||
| MDS9698L | In distribution | ||
| MDSTEMPSCAN | In distribution | ||
| MDS9850B | In distribution | ||
| MDS9950B | 20 | In distribution | |
| MDS9851B | In distribution | ||
| MDS9952B | 20 | 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 |
| Mabis | D-M-S Holdings, Inc. | 34 |
Showing 12 of 843. All products under Continuous Measurement Thermometer
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K211931 | 2021-09-20 |
| K183431 | 2019-06-14 |
| K173113 | 2018-01-17 |
Recalls Naming This Product
2 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Edan Diagnostics, Inc. | 510(k) number | 2025-10-24 | Class II | Device Design | As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device. | 11987 | |
| Philips Consumer Lifestyle | 510(k) number | 2018-02-02 | Class II | Use error | Device may provide inaccurate measurements. | 45141 | 2019-03-29 |
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.