Identity
- Trade Name
- Carewell EUDAMED
- Device Name
- Electrocardiograph EUDAMED
- Model / Reference
- ECG-1112M EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971049341178 EUDAMED
- Basic UDI-DI
- B-06971049341178 EUDAMED
- EMDN Code
- Z12050301 GENERAL PURPOSE ELECTROCARDIOGRAPHS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Spain 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
Carewell 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-06971049341178 | 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 2ac28427-f21b-48c6-b94a-9b23729761af 61 fields · synced May 23, 2026