Regard™
ECG Monitoring Electrodes
6manufacturers in China registered for this device type
25catalogue numbers in this listing
Who Else Makes It
Concentrated in Shandong (3), Shanghai (1), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Linxens Healthcare (Tianjin) Co., Ltd. | Jinnan District | Tianjin | Contract manufacturer | 7 |
| Infitek Co., Ltd. | Shanghai | Shanghai | Manufacturer | 49 |
| Labpeak Co., Ltd. | Jinan | Shandong | Manufacturer | 43 |
| Scitek Global Co., Ltd. | Jinan | Shandong | Manufacturer | 43 |
| Jiangsu Rooe Medical Technology Co., Ltd. | Zhangjiagang | Jiangsu | Manufacturer | 31 |
| China Qingdao Bright Medical Manufacturing Co., Ltd. | Qingdao | Shandong | Contract manufacturer | 8 |
Record
| Listed by | Resource Optimization & Innovation, L.L.C. |
|---|---|
| FDA product code | MLN |
| Device type | Electrode, Electrocardiograph, Multi-Function |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2360 |
| Premarket notification | Exempt |
| Record published | 2019-10-30 |
| Record revised | 2026-05-01 (version 6) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature -20 to 40 °C |
| Packaging | Pack of 10 |
| Distribution end date | 2023-01-03 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 315709 | In distribution | |
| C100AC | In distribution | |
| T100LOAC | In distribution | |
| T100AC-PHILIPS | In distribution | |
| C100AC-ZOLL | In distribution | |
| 315717 | In distribution | |
| T100AC | In distribution | |
| T100AC-PHYSIO | In distribution | |
| C100LOAC | In distribution | |
| PED-100 | In distribution | |
| PEDIATRIC-ZOLL | In distribution | |
| T100AC-ZOLL | In distribution | |
| C100LOAC-PHYSIO | In distribution | |
| C100LOAC-ZOLL | In distribution | |
| T100-CS | In distribution | |
| C100AC-PHYSIO | In distribution | |
| PEDIATRIC-PHILIPS | In distribution | |
| C100AC-PHILIPS | In distribution | |
| T100LOAC-ZOLL | In distribution | |
| 315707 | In distribution | |
| C100LOAC-PHILIPS | In distribution | |
| PEDIATRIC-PHYSIO | In distribution | |
| T100LOAC-PHYSIO | In distribution | |
| T100LOAC-PHILIPS | In distribution | |
| 315708 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medline | Medline Industries, Inc. | 15 |
| Heartsync by Vermed | Graphic Controls Acquisition Corporation | 9 |
| Curaplex | Bound Tree Medical, LLC | 6 |
| Adult/Child, radiotransparent, defib electrodes with increased adhesive surface | Heart Sync, LLC | 6 |
| Henry Schein | Henry Schein, Inc. | 3 |
| MediChoice | Owens & Minor Distribution, Inc. | 3 |
| Adult/Child, radiotransparent, leads out, defib electrodes w/ Phillips connector | Heart Sync, LLC | 3 |
| Adult/Child, radiolucent, leads out, defib electrodes w/ Zoll connector | Heart Sync, LLC | 3 |
| BodyGuardian | Preventice Technologies, Inc. | 3 |
| Zensor electrode | Intelesens Limited | 2 |
| Adult/Child, radiotransparent, defib electrodes w/ Zoll connector | Heart Sync, LLC | 2 |
| Heart Sync Adult/Child Radio Transparent Multi Function Electrodes | Heart Sync, LLC | 2 |
Showing 12 of 24. All products under Electrode, Electrocardiograph, Multi-Function
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.