Identity
- Trade Name
- SZcaremed EUDAMED
- Device Name
- ECG Electrode EUDAMED
- Model / Reference
- EKA-AS-A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06931973429229 EUDAMED
- Basic UDI-DI
- 69707585REE87 EUDAMED
- Direct Marketing DI
- 06931973429229 EUDAMED
- EMDN Code
- C020501 ECG ELECTRODES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Electrocardiographic electrode, single-use
SZcaremed by Shenzhen Caremed Medical Technology Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Electrocardiographic electrode, single-use.
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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 | 69707585REE87 | Class I | Active |
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Manufacturer
- Manufacturer
- Shenzhen Caremed Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000010579
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 7eadaa20-b779-4bc4-a60d-9fd9e838f508 61 fields · synced Jun 20, 2026