Identity
- Trade Name
- Shenzhen Comen Medical Instruments Co., Ltd. EUDAMED
- Device Name
- electrocardiograph EUDAMED
- Model / Reference
- 001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16945429012344 EUDAMED
- Basic UDI-DI
- 694542901234HD EUDAMED
- EMDN Code
- Z12050302 ADVANCED DIAGNOSIS 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Shenzhen Comen Medical Instruments Co., Ltd. by Shenzhen Yuezhongxing 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 | 694542901234HD | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Shenzhen Yuezhongxing Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000024102
- Authorised Representative
- Kingsmead Service B.V. NL-AR-000002066
Sources (1)
- EUDAMED 8862f830-7b0b-4a17-b3a6-fe67bdbd4561 61 fields · synced May 24, 2026