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ClariCT.AI
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref ClariCT.AI510(k) K212074
by ClariPi Inc.
Identity
- Trade Name
- ClariCT.AI EUDAMED
- Device Name
- ClariCT.AI EUDAMED
- Model / Reference
- ClariCT.AI EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-88000468CAI-066B3Z EUDAMED
- Basic UDI-DI
- B-88000468CAI-066B3Z EUDAMED
- EMDN Code
- Z11030692 COMPUTED TOMOGRAPHS (CT) - MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Special Device Type
- -1192 EUDAMED
- Market of Registration
- Poland 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
ClariCT.AI by ClariPI Inc. — 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
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 | K212074 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K183460 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-88000468CAI-066B3Z | Class IIa | Active |
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Manufacturer
- Manufacturer
- ClariPi Inc.
- EUDAMED SRN
- KR-MF-000031518
- FDA Applicant
- Claripi, Inc.
- Authorised Representative
- AR Experts B.V. NL-AR-000023989
Sources (2)
- EUDAMED 986ef3c6-43a5-42a5-b96b-5351f7fcd20c 85 fields · synced Jun 18, 2026
- FDA 510(k) K212074 1 fields · synced May 18, 2026