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Electrocardiograph
EUDAMEDClass IIa (EU MDR)
Ref H12ARef /Model CM1200/CM1200A/CM1200B/H3/H12/H12A
Identity
- Trade Name
- Electrocardiograph EUDAMED
- Device Name
- Electrocardiograph EUDAMED
- Model / Reference
- H12A EUDAMEDCM1200/CM1200A/CM1200B/H3/H12/H12A EUDAMED/ EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06945429020830 EUDAMED
- Basic UDI-DI
- B-06945429020830 EUDAMED69454290EL001KA EUDAMED
- Direct Marketing DI
- 06945429020830 EUDAMED
- EMDN Code
- Z12050301 GENERAL PURPOSE ELECTROCARDIOGRAPHS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Belgium EUDAMEDIreland 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Electrocardiograph by Shenzhen Comen Medical Instruments Co., LTD. — Class IIa — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-06945429020830 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-06945429020830 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shenzhen Comen Medical Instruments Co., LTD.
- EUDAMED SRN
- CN-MF-000002236
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (2)
- EUDAMED 2eea9e98-ad13-42ad-ae55-cd48852f0d55 61 fields · synced Jul 23, 2026
- EUDAMED e1899b19-d9fd-496e-842e-e7a999e1d637 61 fields · synced May 18, 2026