Diagnostix™
Adstation Oto PMV-LED/Coax Oph-LED, 429, ,9003W/Spec Disp, WB, EU
115manufacturers in China registered for this device type
61catalogue numbers in this listing
1510(k) clearance
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 | American Diagnostic Corp., United States |
|---|---|
| FDA product code | FLL |
| Device type | Continuous Measurement Thermometer |
| Device class | Class 2 |
| Regulation | 21 CFR 880.2910 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer |
| 510(k) | K081160 |
| Record published | 2019-12-20 |
| Record revised | 2020-12-04 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Over the counter | Yes |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, manufacturing date |
| Storage | Storage environment humidity 10 to 85 % RH; Storage environment temperature 23 to 122 °F |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5680B-348W | In distribution | |
| 56102X-348W | In distribution | |
| 56102A-349EUW | In distribution | |
| 5610L-347W | In distribution | |
| 5611L-346X7W | In distribution | |
| 56802A-349EUW | In distribution | |
| 56802L-349EUW | In distribution | |
| 5611L-3457W | In distribution | |
| 5680B-349EUW | In distribution | |
| 5680L-348EUW | In distribution | |
| 56802B-349EUW | In distribution | |
| 56102X-349W | In distribution | |
| 56802X-349EUW | In distribution | |
| 5681L-346X8W | In distribution | |
| 56802B-348W | In distribution | |
| 5681X-3458W | In distribution | |
| 5610B-349W | In distribution | |
| 5611L-346X9W | In distribution | |
| 5611X-346X9EUW | In distribution | |
| 5681L-346L9EUW | In distribution | |
| 5610L-348W | In distribution | |
| 56102B-349EUW | In distribution | |
| 5610A-348W | In distribution | |
| 5680A-349EUW | In distribution | |
| 5681X-346X9EUW | In distribution | |
| 5611L-346L8W | In distribution | |
| 5610X-349W | In distribution | |
| 5680X-349EUW | In distribution | |
| 56802X-348W | In distribution | |
| 5611L-3459W | In distribution | |
| 56102B-348W | In distribution | |
| 5610B-348W | In distribution | |
| 5610L-349W | In distribution | |
| 5611L-3458W | In distribution | |
| 56802L-348W | In distribution | |
| 5610X-348W | In distribution | |
| 5681L-346L8W | In distribution | |
| 5680A-348W | In distribution | |
| 5681L-346X9EUW | In distribution | |
| 5611X-346X8W | In distribution | |
| 56102L-348W | In distribution | |
| 5611X-346L8W | In distribution | |
| 5610X-347W | In distribution | |
| 5680L-349EUW | In distribution | |
| 5680X-348W | In distribution | |
| 56102L-349W | In distribution | |
| 5611L-346X8W | In distribution | |
| 5681L-3458W | In distribution | |
| 5681X-346X8W | In distribution | |
| 5680L-348W | In distribution | |
| 56802A-348W | In distribution | |
| 56102X-347W | In distribution | |
| 5611X-346L9EUW | In distribution | |
| 5610B-347W | In distribution | |
| 56102A-348W | In distribution | |
| 5610A-347W | In distribution | |
| 5610A-349W | In distribution | |
| 5611L-346L7W | In distribution | |
| 5611L-346L9W | In distribution | |
| 5681X-346L9EUW | In distribution | |
| 5681X-346L8W | 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 |
| 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 |
| Mabis | D-M-S Holdings, Inc. | 34 |
Showing 12 of 843. All products under Continuous Measurement Thermometer
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K940686 | 1994-07-08 |
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.