Identity
- Device Name
- Electrocardiograph EUDAMED
- Model / Reference
- ECG1212 EUDAMED/ EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06922649906014 EUDAMED
- Basic UDI-DI
- B-06922649906014 EUDAMED
- EMDN Code
- Z12050301 GENERAL PURPOSE ELECTROCARDIOGRAPHS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Türkiye 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 Beijing M&B Electronic Instruments 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-06922649906014 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Beijing M&B Electronic Instruments Co., Ltd.
- EUDAMED SRN
- CN-MF-000010160
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED ccc47f6e-cb34-42d6-9ca2-b8a9764ab7af 61 fields · synced Jun 18, 2026