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CardioExpress 5012
EUDAMEDClass IIa (EU MDR)
Ref manyModel Cardio Q50 / Cardio Q70
Identity
- Trade Name
- CardioExpress 5012 EUDAMED
- Device Name
- Electrocardiographs & Spirometers EUDAMED
- Model / Reference
- Cardio Q50 / Cardio Q70 EUDAMEDmany EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809276944276 EUDAMED
- Basic UDI-DI
- 880927694CQ57NE EUDAMED
- Direct Marketing DI
- 08809276944276 EUDAMED
- EMDN Code
- Z12050301 GENERAL PURPOSE ELECTROCARDIOGRAPHS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France 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
CardioExpress 5012 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 | 880927694CQ57NE | 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 4bb41a8e-0df0-4971-ac45-8ed3d670516c 61 fields · synced Jun 19, 2026