Identity
- Trade Name
- PC-Based Resting ECG EUDAMED
- Device Name
- PC-Based Resting ECG EUDAMED
- Model / Reference
- ECG-D12 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719873790029 EUDAMED
- Basic UDI-DI
- B-04719873790029 EUDAMED
- EMDN Code
- Z12050301 GENERAL PURPOSE ELECTROCARDIOGRAPHS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Spain 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
PC-Based Resting ECG by Britemed Technology Inc. — 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-04719873790029 | Class IIa | Active |
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Manufacturer
- Manufacturer
- BriteMED Technology Inc.
- EUDAMED SRN
- TW-MF-000028387
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED 2bfb9293-1b18-4bd2-93f4-74eb881db953 61 fields · synced Jun 19, 2026