Identity
- Device Name
- Electrocardiograph EUDAMED
- Model / Reference
- ECG-1112L EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971049341109 EUDAMED
- Basic UDI-DI
- B-06971049341109 EUDAMED
- EMDN Code
- Z12050301 GENERAL PURPOSE ELECTROCARDIOGRAPHS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Electrocardiograph by Shenzhen Carewell EIectronics Co., Ltd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06971049341109 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shenzhen Carewell EIectronics Co., Ltd.
- EUDAMED SRN
- CN-MF-000026800
- Authorised Representative
- Lepu Medical (Europe) Cooperatief U.A. NL-AR-000000551
Sources (1)
- EUDAMED 1bf97b34-e40f-45ad-8072-c74b40dff57e 61 fields · synced Jun 19, 2026