PADECG PC ECG
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Identity
- Trade Name
- PC ECG EUDAMEDFDA UDI
- Generic Name
- Electrocardiograph, professional, multichannel FDA UDI
- Device Name
- PC ECG EUDAMED
- Model / Reference
- PADECG EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06944413802759 EUDAMEDFDA UDI
- Basic UDI-DI
- 69444138PADECGPK EUDAMED
- 510(k) Number
- K161302 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
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
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
Yes
Incorporates Medicinal Product
No
Prescription Use
Yes
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 PADECG PC ECG is a portable electrocardiogram (ECG) device, classified under nomenclature code Z12050301. It is designed to record and display the electrical activity of the heart, providing diagnostic information for assessing cardiac function and detecting abnormalities such as arrhythmias or ischemia.
This device is intended for single-use and is non-sterile, non-reusable, and non-implantable. It operates as an active medical device and is supplied with a unique device identifier (UDI) for traceability. Authorized under FDA 510K and MDR, the PADECG is classified as Class IIa and is intended for use in clinical settings, including hospitals and physician offices, where cardiac monitoring is required. Storage and handling should follow manufacturer guidelines to maintain device integrity.
Frequently asked questions
Is the PC ECG device designed for repeated use in clinical settings, or is it intended for single-use only?
The PC ECG is explicitly designed for single-use only, as indicated by the ‘REUSABLE: 0’ field in the specifications. This means each device is intended to be used once and then discarded, ensuring patient safety and compliance with manufacturer guidelines for device integrity.
What storage and handling precautions should be taken for the PC ECG to maintain its performance?
While the data does not specify exact storage conditions, the device’s non-sterile, non-reusable, and single-use nature implies it should be stored in a clean, dry environment away from extreme temperatures or direct sunlight. Adhering to the manufacturer’s guidelines (referenced in the description) is critical to preserving its functionality and traceability via the included UDI.
Does the PC ECG come in multiple sizes or models, or is it available as a single standardized unit?
The specifications list a single model: PADECG, with no mention of variants or sizes. This suggests it is supplied as a uniform, portable ECG device without customizable configurations, making it suitable for general cardiac monitoring in clinical settings like hospitals or physician offices.
How is the PC ECG regulated, and what does its classification as Class IIa imply for its use?
The PC ECG is authorized under FDA 510K (K161302) and MDR, with a classification of Class IIa, indicating it poses a moderate risk. This classification means it undergoes stricter scrutiny than Class I devices but is not as high-risk as Class III. Clinically, it is intended for diagnostic cardiac monitoring (e.g., detecting arrhythmias or ischemia) in controlled settings like hospitals or offices, where trained personnel operate it.
Can the PC ECG be used outside of clinical environments, or is it restricted to professional healthcare settings?
The device is intended for clinical settings, such as hospitals and physician offices, as stated in the description. While it is portable, its classification as a Class IIa active medical device and lack of consumer-grade labeling suggest it is not designed for home use or self-administration by untrained individuals. Professional supervision is implied for accurate interpretation of ECG results.
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
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K161302 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K131819 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K152427 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K102854 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K160876 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 69444138PADECGPK | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Edan Instruments, Inc.
- EUDAMED SRN
- CN-MF-000009957
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (3)
- EUDAMED 2d040673-0268-4934-b3d4-92b528a138a9 85 fields · synced Sep 18, 2026
- FDA UDI b5920479-a86e-450f-8869-4e401efc11d9 33 fields · synced May 30, 2026
- FDA 510(k) K161302 1 fields · synced May 18, 2026