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EKG Series
EUDAMEDClass IIa (EU MDR)
Ref EKGI, EKGIIModel EKG Series
by International Group medical technology and electronics GmbH
Identity
- Trade Name
- EKG Series EUDAMED
- Device Name
- Electrocardiograph EUDAMED
- Model / Reference
- EKG Series EUDAMEDEKGI, EKGII EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04255716700041 EUDAMED
- Basic UDI-DI
- 42557167IGEKGKK EUDAMED
- EMDN Code
- Z12050301 GENERAL PURPOSE ELECTROCARDIOGRAPHS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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
EKG Series by International Group medical technology and electronics GmbH — 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 | 42557167IGEKGKK | Class IIa | Active |
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Manufacturer
- EUDAMED SRN
- DE-MF-000025679
Sources (2)
- EUDAMED 801a1782-2718-46d3-a55a-dfd61005989d 61 fields · synced Jul 27, 2026
- EUDAMED 801a1782-2718-46d3-a55a-dfd61005989d-1 61 fields · synced Jun 9, 2026