Identity
- Device Name
- Electrocardiograph EUDAMED
- Model / Reference
- Cardio P1 EUDAMEDmany EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809276943972 EUDAMED
- Basic UDI-DI
- 880927694CP1SW EUDAMED
- Direct Marketing DI
- 08809276943972 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
Electrocardiograph by Bionet Co., Ltd. — 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 | 880927694CP1SW | Class IIa | Active |
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Manufacturer
- Manufacturer
- Bionet Co., Ltd.
- EUDAMED SRN
- KR-MF-000013439
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED b288a86b-11b6-45b5-a7b4-b673b8abcd46 61 fields · synced Aug 2, 2026