Digital Electrocardiograph iE 15
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Identity
- Trade Name
- Digital Electrocardiograph EUDAMEDFDA UDI
- Generic Name
- Electrocardiograph, professional, multichannel FDA UDI
- Device Name
- Digital Electrocardiograph EUDAMED
- Model / Reference
- iE 15 EUDAMED90120122 EUDAMEDiE15 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06937683415125 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06937683415125 EUDAMED
- 510(k) Number
- K141946 FDA UDI
- FDA Product Code
- DPS FDA UDI
- EMDN Code
- Z12050301 GENERAL PURPOSE ELECTROCARDIOGRAPHS EUDAMED
- GMDN Term
- Electrocardiograph, professional, multichannel FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2340 FDA UDI
- Market of Registration
- Poland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Administering Medicine
No
Measuring Function
Yes
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
The Digital Electrocardiograph iE 15 is a Class IIa medical device classified under nomenclature code Z12050301, designed for electrocardiographic recording and analysis. It measures electrical activity of the heart to generate a graphical representation of cardiac function, aiding in the diagnosis of arrhythmias, ischemia, and other cardiac conditions.
This device is non-sterile, non-reusable, and non-implantable, intended for single-use in clinical or home settings. Supplied with a unique Basic UDI (B-06937683415125), it is authorized under FDA 510K clearance (K141946) and the Medical Devices Directive (MDD). The device is active and equipped for measuring functions, requiring proper storage and handling as a non-reprocessed, non-latex item.
Frequently asked questions
What clinical conditions can this device help diagnose based on its intended use?
The Digital Electrocardiograph iE 15 is designed to measure the heart’s electrical activity and generate a graphical representation (ECG tracing) to aid in diagnosing conditions such as arrhythmias and ischemia. These conditions involve irregular heart rhythms or blood flow restrictions, respectively, which the device helps identify through its electrocardiographic recording and analysis capabilities.
Is this device intended for use in both clinical and home settings, and how is it supplied?
Yes, the Digital Electrocardiograph iE 15 is intended for single-use in *both* clinical environments (e.g., hospitals) and home settings. It is supplied as a non-sterile, non-reusable, and non-implantable device, meaning it is not meant for reprocessing or implantation. Each unit comes with a unique Basic UDI (B-06937683415125) for traceability.
How should this device be stored, and what materials should be avoided during handling?
Since the iE 15 is non-reprocessable and non-latex, it must be stored in its original packaging under conditions that preserve its functionality. Avoid exposure to moisture, extreme temperatures, or physical damage. Additionally, because it is non-latex, users with latex allergies can safely handle it without risk of allergic reactions.
What regulatory pathways does this device follow, and who is the authorized distributor in Europe?
The Digital Electrocardiograph iE 15 is authorized under the FDA’s 510(k) clearance (K141946) and the Medical Devices Directive (MDD). In Europe, the authorized representative is **Shanghai International Holding Corp. GmbH (Europe)**, based in Germany (SRN: DE-AR-000000001). This ensures compliance with regional regulatory requirements for medical devices.
Are there multiple models or sizes available for this device, or is the iE 15 the only version?
The provided data specifies only one model of this device: the **Digital Electrocardiograph iE 15**. There are no indications of alternative models or sizes listed, so this appears to be the sole version available for purchase or 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.
Authorization Coverage (2 countries)
Regulatory Authorizations
FDA_510K
FDA_510K
FDA_510K
FDA_510K
FDA_510K
FDA_510K
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K132758 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K152384 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K133985 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K171517 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K160092 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K141946 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-06937683415125 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shenzhen Biocare Bio-Medical Equipment Co., Ltd.
- EUDAMED SRN
- CN-MF-000005653
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (3)
- EUDAMED 2a5a4667-a59d-4f30-8ea0-8dfdb365f046 85 fields · synced Oct 6, 2026
- FDA UDI 113b54dc-afc9-45f9-9747-bfce4c09d68f 33 fields · synced May 30, 2026
- FDA 510(k) K132758 1 fields · synced May 18, 2026