HD+12
Digital portable acquisition device which can acquire the electrocardiographic signal of 12 standard leads. Connected with a receiver via Bluetooth or USB, sends the data to the host.
11manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Guangdong (5), Jiangsu (2), Zhejiang (2). 4 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 |
| Linxens Healthcare (Tianjin) Co., Ltd. | Jinnan District | Tianjin | Contract manufacturer | 7 |
| Dongguan CFE Electronic Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 2 |
| Chero Technology Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 1 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| Edan Instruments, Inc. | Shenzhen | Guangdong | Contract manufacturer | 56 |
| Orantech Inc. | Shenzhen | Guangdong | Contract manufacturer | 40 |
| Suzhou Prosteri Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 20 |
| Avita (Wujiang) Co., Ltd. | Wujiang | Jiangsu | Contract manufacturer | 15 |
| Hangzhou VivaLNK Medical Technology Co., Ltd. | Hangzhou | Zhejiang | Exporter | 4 |
Record
| Listed by | Cardioline SPA |
|---|---|
| FDA product code | DRG |
| Device type | Transmitters And Receivers, Physiological Signal, Radiofrequency |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2910 |
| Record published | 2025-02-26 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Handling environment temperature 0 to 40 °C; Storage environment temperature 5 to 40 °C; Handling environment humidity 15 to 90 % RH; Storage environment humidity 15 to 90 % RH; Handling environment atmospheric pressure 54 to 106 KiloPascal; Storage environment atmospheric pressure 54 to 106 KiloPascal |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| HD+12 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Vital Sync | Covidien LP | 29 |
| Transmitters And Receivers, Physiological Signal, Radiofrequency | Nihon Kohden Corp. | 22 |
| LifeSync | LifeSync Corporation | 18 |
| Surveyor Patient Cable | Mortara Instrument, Inc. | 18 |
| Isansys | Isansys Lifecare, Ltd. | 15 |
| ZephyrLIFE Home | Zephyr Technology Corporation | 11 |
| Transmitters And Receivers, Physiological Signal, Radiofrequency | Nihon Kohden America, Inc. | 9 |
| InTouch Health | Intouch Health, Inc. | 7 |
| UbiqVue | LifeSignals, Inc. | 6 |
| X12+ | Mortara Instrument, Inc. | 5 |
| Welch Allyn, Inc. | Welch Allyn, Inc. | 5 |
| Ezypro ECG Recorder | Sigknow Biomedical Co., Ltd. | 3 |
Showing 12 of 211. All products under Transmitters And Receivers, Physiological Signal, Radiofrequency
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.