Disposable ECG Cable and Leadwires
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- ECG Cable and Leadwires EUDAMED
- Device Name
- Patient Cable and leadwires EUDAMED
- Model / Reference
- EJD040C3I EUDAMEDEE051C5A-M EUDAMEDEJD040P5A EUDAMEDEA055C3I EUDAMEDEJ050-5AI EUDAMEDEJ040S5I EUDAMEDEC018S3A EUDAMEDEH040A3A EUDAMEDEL024E3I EUDAMEDEC029-3AI EUDAMEDEND405P3I EUDAMEDEA003S5A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06944414088145 EUDAMED06944414001342 EUDAMED06944414032940 EUDAMED06944414051316 EUDAMED06944414027083 EUDAMED06944414003179 EUDAMED06944414088374 EUDAMED06944414002035 EUDAMED06944414031189 EUDAMED06944414025638 EUDAMED06944414068529 EUDAMED06944414041096 EUDAMED06944414000161 EUDAMED
- Basic UDI-DI
- 69444140001SE EUDAMED
- 510(k) Number
- K220447 FDA 510(k)
- FDA Product Code
- DSA FDA 510(k)
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.2900 FDA 510(k)
- Regulation Number
- 870.2900 FDA 510(k)
- Market of Registration
- Germany EUDAMEDItaly EUDAMED
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
This device is a Cable, Transducer and Electrode, Patient (Including Connector) designed for electrocardiogram (ECG) monitoring. It facilitates the transmission of electrical signals from ECG electrodes to monitoring equipment, enabling real-time cardiac rhythm assessment in clinical settings.
The disposable cable and leadwires are intended for single-patient use to minimize cross-contamination risks. Supplied sterile and classified as Device Class II, they are regulated under FDA 510(k) clearance and MDR. Compatible with standard ECG monitoring systems, these leadwires are non-reusable and require proper disposal after use to maintain infection control standards.
Frequently asked questions
Are these ECG cables designed for reuse or are they single-use only, and why does that matter?
The Med-link Disposable ECG Cable and Leadwires are explicitly designed for single-patient use only. This is critical for infection control, as single-use minimizes cross-contamination risks between patients. Reuse is not recommended or supported, and proper disposal after use is required to maintain clinical safety standards.
How are these leadwires supplied, and do they come in a sterile package?
The Med-link Disposable ECG Cable and Leadwires are supplied sterile and ready for immediate clinical use. Since they are classified as Class II medical devices, sterility is a key feature to ensure patient safety during ECG monitoring.
What types of ECG monitoring systems are compatible with these leadwires?
These leadwires are designed to be compatible with standard ECG monitoring systems, ensuring seamless integration for real-time cardiac rhythm assessment in clinical settings. No additional adapters or modifications are required.
How do I properly store these leadwires before use?
While the data does not specify storage conditions, as a sterile, single-use medical device, these leadwires should be stored in a clean, dry environment away from direct sunlight or extreme temperatures. Always follow manufacturer guidelines to preserve sterility and functionality until use.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: MED-LINKET - SpO2 sensors-ECG/ lead wires-NIBP-EEG Electrodes ..., Products - Shenzhen Med-Link Electronics Tech Co.,Ltd, Disposable ECG Leadwires OEM#33103 - Med-link Electronics Tech - PDF ...
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K220447 | Class II | Active |
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Manufacturer
- Manufacturer
- Shenzhen Med-Link Electronics Tech Co., Ltd.
Sources (14)
- FDA 510(k) K220447 24 fields · synced Sep 18, 2026
- EUDAMED 48fb390a-3ab7-4233-ab5a-87bb3a380519 61 fields · synced Jul 8, 2026
- EUDAMED c2c09c43-d037-4a30-a0dd-d162a753e26d 61 fields · synced Jul 8, 2026
- EUDAMED f471bebf-41f5-48bb-82db-eb40e4999533 61 fields · synced Jul 8, 2026
- EUDAMED 1fa12fcf-1316-4539-b13e-a772a6adf2be 61 fields · synced Jul 8, 2026
- EUDAMED 41d4054c-356a-43a3-a72b-4418dab0331b 61 fields · synced Jul 9, 2026
- EUDAMED 9565dca8-2d52-4047-9d0e-7cb2b0f8caf3 61 fields · synced Jul 14, 2026
- EUDAMED 6a7a3478-c4d7-42dc-b0c9-f6c0a4fae461 61 fields · synced Aug 1, 2026
- EUDAMED d983de9c-3801-41ee-aaeb-89cff17703a9 61 fields · synced Aug 1, 2026
- EUDAMED 8122c67b-e0dd-4fad-8392-772ce810ea97 61 fields · synced Aug 1, 2026
- EUDAMED 3fcc76ec-8a93-49c3-a0c0-dbcfe3ffb6a2 61 fields · synced Aug 1, 2026
- EUDAMED b5975d2e-32f3-4d2a-b9c7-9ddb93d1db56 61 fields · synced Aug 1, 2026
- EUDAMED baa41c50-4caa-4757-b397-57058c5813f5 61 fields · synced Aug 1, 2026
- EUDAMED 911f88a0-7f64-43ca-9fc3-7e94be8d7d76 61 fields · synced Aug 1, 2026