Identity
- Trade Name
- CAAS Qardia EUDAMED
- Device Name
- CAAS Qardia 1.0 EUDAMED
- Model / Reference
- CAAS Qardia EUDAMED1.0 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08056304454355 EUDAMED
- Basic UDI-DI
- B-08056304454355 EUDAMED
- EMDN Code
- Z11039082 VARIOUS RADIODIAGNOSTIC AND INTERVENTIONAL INSTRUMENTS - SOFTWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Special Device Type
- -1192 EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
CAAS Qardia by Pie Medical Imaging B.v. — Class IIa — FDA_510K, MDD — 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/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K212376 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-08056304454355 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Pie Medical Imaging B.V.
- EUDAMED SRN
- NL-MF-000001540
Sources (2)
- EUDAMED 51fdaa55-c76f-4721-9cf7-90a5ebcd9cfc 61 fields · synced Jul 12, 2026
- FDA 510(k) K212376 1 fields · synced May 18, 2026