Identity
- Trade Name
- electrocardiograph EUDAMED
- Device Name
- Electrocardiograph EUDAMED
- Model / Reference
- ECG 301 EUDAMED06975070970031 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975070970031 EUDAMED
- Basic UDI-DI
- 6975070970000AQ EUDAMED
- EMDN Code
- Z12050301 GENERAL PURPOSE ELECTROCARDIOGRAPHS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
electrocardiograph by Shenzhen Le Medical Technology Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 6975070970000AQ | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shenzhen Le Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000007686
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 90022cf1-0627-474e-bd8f-231d358a2f9f 61 fields · synced May 23, 2026