Identity
- Device Name
- ECG Analyzer EUDAMED
- Model / Reference
- ECG Analyzer-1 EUDAMED/ EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976589110017 EUDAMED06976589110024 EUDAMED
- Basic UDI-DI
- 697658911ECGAnalyzer-15J EUDAMED
- EMDN Code
- Z12050392 ELECTROCARDIOGRAPHS - MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class IIb 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
ECG Analyzer by Shenzhen OPPO Health Technology Corp., Ltd. — Class IIb — 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 | 697658911ECGAnalyzer-15J | Class IIb | Active |
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Manufacturer
- Manufacturer
- Shenzhen OPPO Health Technology Corp., Ltd.
- EUDAMED SRN
- CN-MF-000041322
- Authorised Representative
- Share info GmbH DE-AR-000005132
Sources (2)
- EUDAMED ceb0629f-ac99-45a0-8abc-560be7a235f4 61 fields · synced Jul 23, 2026
- EUDAMED 203e3498-5cb2-4cd7-bdfb-79eb4891601d 61 fields · synced May 17, 2026