← Back to catalogue
Cardio Q50
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref manyModel Cardio Q50 / Cardio Q70
Identity
- Trade Name
- Cardio Q50 EUDAMED
- Device Name
- Electrocardiographs & Spirometers EUDAMED
- Model / Reference
- Cardio Q50 / Cardio Q70 EUDAMEDmany EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809276943958 EUDAMED
- Basic UDI-DI
- 880927694CQ57NE EUDAMED
- Direct Marketing DI
- 08809276943958 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
Cardio Q50 by Bionet Co., Ltd. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K231160 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 880927694CQ57NE | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Bionet Co., Ltd.
- EUDAMED SRN
- KR-MF-000013439
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (2)
- EUDAMED 9861a5a3-42c4-4ac0-8408-64c3d608810f 61 fields · synced Jul 9, 2026
- FDA 510(k) K231160 1 fields · synced May 18, 2026