Identity
- Trade Name
- CoroFlow Cardiovascular System EUDAMED
- Device Name
- CoroFlow Cardiovascular system EUDAMED
- Model / Reference
- 12000WW EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07350111070038 EUDAMED
- Basic UDI-DI
- 7350111071205A EUDAMED
- Direct Marketing DI
- 07350111070038 EUDAMED
- EMDN Code
- Z12050782 INSTRUMENTS FOR CARDIOLOGICAL POLYGRAPHY - SOFTWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
CoroFlow Cardiovascular System by Coroventis Research Ab — 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
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 | K252238 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K201881 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 7350111071205A | Class IIa | Active |
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Manufacturer
- Manufacturer
- Coroventis Research AB
- EUDAMED SRN
- SE-MF-000002888
Sources (2)
- EUDAMED 6467634f-960e-4948-af72-ad15dfc089db 61 fields · synced Jul 13, 2026
- FDA 510(k) K252238 1 fields · synced May 18, 2026