Data / Medical devices / Electrode, Electrocardiograph, Multi-Function
Electrode, Electrocardiograph, Multi-Function (MLN): 16 FDA-registered makers in 6 countries
16 establishments in 6 countries are registered with the FDA to make Electrode, Electrocardiograph, Multi-Function (product code MLN, Class 2, 21 CFR 870.2360). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 0 510(k) clearances under this code, and lists 6 recall events (0 Class I). FDA data exported November 3, 2026.
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- Product code
- MLN
- Device class
- 2
- Regulation
- 870.2360
- Medical specialty
- Cardiovascular
Makers by country
| Country | Makers |
|---|---|
| China | 7 |
| United States | 5 |
| Austria | 1 |
| Sweden | 1 |
| Canada | 1 |
| Turkey | 1 |
Makers of Electrode, Electrocardiograph, Multi-Function
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Ari Medical Technology Co., Ltd. | Hefei Anhui, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Boston Scientific Cardiac Diagnostic Technologies, Inc. | Rochester, MN, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Boston Scientific Cardiac Diagnostic Technologies, Inc. | Arden Hills, MN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| China Qingdao Bright Medical Manufacturing Co.,ltd. | Qingdao Shandong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cardinal Health | Hazelwood, MO, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Infitek Co., Ltd. | Shanghai, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu Rooe Medical Technology Co., Ltd. | Zhangjiagang City Jiangsu, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Katecho LLC | Des Moines, IA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Labpeak Co.,ltd | Jinan Shandong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Leonhard Lang GMBH | INNSBRUCK Tirol, Austria | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Linxens Healthcare (Tianjin) Co., Ltd | JinNan District Tianjin, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Linxens Sweden AB | Angelholm Skane, Sweden | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ludlow Technical Products Canada, Ltd. (A Division of Cardinal Health LLC) | GANANOQUE Ontario, Canada | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Scitek Global Co.,ltd | Jinan Shandong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| The Electrode Store | Buckley, WA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasal Urun | ESENYURT Istanbul, Turkey | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 3, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.