Agelh
24 catalogue numbers from BA-805X, listed by Dongguan E-Test Technology Co., Ltd., China, under System, Measurement, Blood-Pressure, Non-Invasive. 98 manufacturers in China are registered for this product code.
98manufacturers in China registered for this device type
24catalogue numbers in this listing
4510(k) clearances naming this product code
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 | Dongguan E-Test Technology Co., Ltd., China |
|---|---|
| FDA product code | DXN |
| Device type | System, Measurement, Blood-Pressure, Non-Invasive |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1130 |
| Establishment | Repacker / relabeller, Private-label distributor, Complaint-file establishment, Manufacturer |
| 510(k) | K193627 |
| Record published | 2020-12-18 |
| Record revised | 2021-12-27 (version 3) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Label carries | lot or batch number, manufacturing date, serial number |
| Packaging | Pack of 24, carton of 36, pack of 36, pack of 8, carton of 24 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| BA-805X | In distribution | |
| BA-801X | In distribution | |
| BA-821X | In distribution | |
| BA-806X | In distribution | |
| BA-818 | In distribution | |
| BA-802X | In distribution | |
| BA-812X | In distribution | |
| BW-605 | In distribution | |
| BW-611 | In distribution | |
| BW-612 | In distribution | |
| BA-823X | In distribution | |
| BW-606 | In distribution | |
| BA-819 | In distribution | |
| BW-603 | In distribution | |
| BA-816 | In distribution | |
| BA-815 | In distribution | |
| BW-602 | In distribution | |
| BW-613 | In distribution | |
| BA-813X | In distribution | |
| BA-803X | In distribution | |
| BW-601 | In distribution | |
| BA-822X | In distribution | |
| BA-811X | In distribution | |
| BA-826X | In distribution |
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 |
| Diagnostix™ | American Diagnostic Corp. | 54 |
| 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 |
Showing 12 of 1,292. All products under System, Measurement, Blood-Pressure, Non-Invasive
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K250231 | 2025-09-03 |
| K193627 | 2020-07-12 |
| K193628 | 2020-07-12 |
| K193624 | 2020-07-10 |
Recalls Naming This Product
4 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 |
|---|---|---|---|---|---|---|
| Medline Industries, LP – Northfield | 510(k) number | 2024-08-30 | Class II | Under Investigation by firm | It has been determined that certain Blood Pressure Monitors containing a faulty microchip have failed to power on or have shown display screen issues after the initial few uses, as well as overheating at times making the unit warm to the to | 52,521 units |
| Medline Industries, LP – Northfield | 510(k) number | 2024-08-30 | Class II | Under Investigation by firm | It has been determined that certain Blood Pressure Monitors containing a faulty microchip have failed to power on or have shown display screen issues after the initial few uses, as well as overheating at times making the unit warm to the to | 9.608 units |
| Medline Industries, LP – Northfield | 510(k) number | 2024-08-30 | Class II | Under Investigation by firm | It has been determined that certain Blood Pressure Monitors containing a faulty microchip have failed to power on or have shown display screen issues after the initial few uses, as well as overheating at times making the unit warm to the to | 7,428 units |
| Medline Industries, LP – Northfield | 510(k) number | 2024-02-26 | Class II | Nonconforming Material/Component | The firm provided a set of specifications for the device, but some units of the device were manufactured non-compliant with the specifications. However, the firms Receiving Dept. accepted these units into inventory | 74,339 units |
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.