Diagnostix™
Adstation Oto-Xen/Coax+Oph-Xen, 429, ,9003W/Spec Disp, WB, EU
98manufacturers in China registered for this device type
54catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (67), Jiangsu (11), Zhejiang (6). 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 |
| Andon Health Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 22 |
| Taizhou Rich Medical Products Co., Ltd. | Taizhou | Jiangsu | Contract manufacturer | 20 |
| Medwell Technology Limited | Dongguan | Guangdong | Contract manufacturer | 10 |
| Honsun (Nantong) Co., Ltd. | Nantong | Jiangsu | Contract manufacturer | 9 |
| EMI (Dongguan) Asia Limited | Dongguan | Guangdong | Contract manufacturer | 9 |
| Yahorng Dongguan Electronic Co Ltd | Guangdong | Guangdong | Contract manufacturer | 8 |
| Guangzhou Daxin Health Technology (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 7 |
| Omron (Dalian) Co., Ltd. (Plant 1) | Dalian | Liaoning | Contract manufacturer | 7 |
| Wuhan Strong Electronics | Wuhan | Hubei | Contract manufacturer | 6 |
| Dongguan Polygreen Technology Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 4 |
| Shenzhen Brav Electronic Technologies Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 3 |
Showing 12 of 98. All 98 manufacturers in China registered for System, Measurement, Blood-Pressure, Non-Invasive
Record
| Listed by | American Diagnostic Corp., United States |
|---|---|
| FDA product code | DXN |
| Device type | System, Measurement, Blood-Pressure, Non-Invasive |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1130 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer |
| 510(k) | K061086 |
| Record published | 2020-01-02 |
| Record revised | 2019-11-08 (version 5) |
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 |
| Packaging | Master case of 4, inner pack of 3, master case of 2, inner pack of 12, master case of 12 |
| Distribution end date | 2019-04-09 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5610X-38EUW | In distribution | |
| 9002DK-MCC | 3 Cuff, 19-50cm | In distribution |
| 56102X-348EUW | In distribution | |
| 6012N | Adult, 22-32cm | In distribution |
| 56802L-38W | In distribution | |
| 5611X-36X8W | In distribution | |
| 9000TOP | In distribution | |
| 6023N | Wide Range, 22-46cm | In distribution |
| 5610B-348EUW | In distribution | |
| 6015N | Adult, 13.5-19.5cm | In distribution |
| 56802A-38W | In distribution | |
| 6021NX | Large Adult, 32-52cm | In distribution |
| 6021NSA | Small Adult, 17-22cm | In distribution |
| 9000TWRKIT | 3 Cuff, 19-50cm | In distribution |
| 5680L-38W | In distribution | |
| 56802B-38W | In distribution | |
| 9000TWBKIT | In distribution | |
| 802ST | In distribution | |
| 9000TRP | In distribution | |
| 5610B-38EUW | In distribution | |
| 5610B-38W | In distribution | |
| 5681L-36L8W | In distribution | |
| 6022N | Wide Range, 22-42cm | In distribution |
| 56102L-38W | In distribution | |
| 5611L-36L8W | In distribution | |
| 5611X-358EUW | In distribution | |
| 56102B-38EUW | In distribution | |
| 5611X-3458EUW | In distribution | |
| 5681X-36X8W | In distribution | |
| 6021SA | Small Adult, 19-23.8cm | In distribution |
| 56102X-38EUW | In distribution | |
| 9002MK-MCC | 3 Cuff, 19-50cm | In distribution |
| 56102B-348EUW | In distribution | |
| 56102A-38W | In distribution | |
| 9000QCF-10 | In distribution | |
| 5680A-38W | In distribution | |
| 6016N | Adult, 13.5-19.5cm | In distribution |
| 5611L-36X8W | In distribution | |
| 5681L-36X8W | In distribution | |
| 6023NZAC | In distribution | |
| 5680X-38W | In distribution | |
| 9002WK-MCC | 3 Cuff, 19-50cm | In distribution |
| 6023NPC | In distribution | |
| 5610A-38W | In distribution | |
| 56802X-38W | In distribution | |
| 6021N | Adult, 22-42cm | In distribution |
| 5610L-38W | In distribution | |
| 9000QCM-10 | In distribution | |
| 5611X-36L8W | In distribution | |
| 5681X-36L8W | In distribution | |
| 5680B-38W | In distribution | |
| 5680L-38EUW | In distribution | |
| 5610X-348EUW | In distribution | |
| 6017PC | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Baum | W.A. Baum Co., Inc. | 116 |
| Alphamed | Shenzhen Urion Technology Co., Ltd. | 68 |
| Electronic Blood Pressure Monitor | Shenzhen Pango Electronic Co., Ltd. | 59 |
| Arm Type Automatic Blood Pressure Monitor | Shenzhen Jiacom Technology Co., Ltd. | 58 |
| A&D Medical | A&D Company, Ltd. | 56 |
| Lutech | Lutech Industries | 51 |
| Veridian | Veridian Healthcare | 50 |
| Hopkins Medical Products® | Hopkins Uniform Company | 49 |
| Welch Allyn, Inc. | Welch Allyn, Inc. | 49 |
| Merit Medical® | Argon Critical Care Systems Singapore PTE. Ltd. | 48 |
| SunTech | Suntech Medical, Inc. | 46 |
| System, Measurement, Blood-Pressure, Non-Invasive | Shenzhen Urion Technology Co., Ltd. | 44 |
Showing 12 of 1,292. All products under System, Measurement, Blood-Pressure, Non-Invasive
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.