Edan Electrocardiograph SE-1201 Pro
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Identity
- Trade Name
- Electrocardiograph EUDAMEDFDA UDI
- Generic Name
- Electrocardiograph, professional, multichannel FDA UDI
- Device Name
- Electrocardiograph EUDAMED
- Model / Reference
- SE-1201 Pro EUDAMEDSE-1201Pro FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06944413820562 EUDAMEDFDA UDI
- Basic UDI-DI
- 69444138SE1201PROS8Y EUDAMED
- 510(k) Number
- K222902 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 Edan Electrocardiograph SE-1201 Pro is a medical device designed to record the electrical activity of the heart over a period of time. It functions as a measuring device to assist in cardiovascular assessment and diagnostics.
This device is manufactured by Edan Instruments, Inc. and is authorized under both FDA 510(k) and MDR regulations. It is classified as a Class IIa device and is intended for professional clinical environments.
Frequently asked questions
Is the Edan SE-1201 Pro sterile?
No, the device is not supplied sterile, as it is an electronic monitoring instrument rather than a surgical or invasive tool.
What is the regulatory classification of this electrocardiograph?
The device is classified as a Class IIa medical device, indicating it is subject to specific regulatory requirements for safety and performance.
Does the SE-1201 Pro contain latex?
No, the specifications confirm that the device does not contain latex.
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: Transforming Cardiac Care: EDAN's Journey in ECG Innovation, EDAN 理邦仪器, [PDF] April 7, 2022 Edan Instruments, Inc. Ying Dai Regulatory ..., EDAN SE-1201 Pro Electrocardiograph - YouTube, ECG SE-3/300-Edan
Authorization Coverage (2 countries)
Regulatory Authorizations
FDA_510K
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 | K170995 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K212278 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K120188 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K102830 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K171943 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K171942 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 69444138SE1201PROS8Y | Class IIa | Active |
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Manufacturer
- Manufacturer
- Edan Instruments, Inc.
- EUDAMED SRN
- CN-MF-000009957
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (3)
- EUDAMED 50089734-734c-4424-99cf-50c4077d3150 85 fields · synced Sep 18, 2026
- FDA UDI a744ed01-98c1-4f2d-8353-c81ac2ca9102 33 fields · synced May 30, 2026
- FDA 510(k) K170995 1 fields · synced May 18, 2026