Identity
- Trade Name
- ClariSIGMAM EUDAMED
- Device Name
- ClariSIGMAM EUDAMED
- Model / Reference
- ClariSIGMAM EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-88000468SMM-13HQPS EUDAMED
- Basic UDI-DI
- B-88000468SMM-13HQPS EUDAMED
- EMDN Code
- Z11030692 COMPUTED TOMOGRAPHS (CT) - MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Special Device Type
- -1192 EUDAMED
- Market of Registration
- Hungary 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
ClariSIGMAM by ClariPI Inc. — Class I — 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 | K203785 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-88000468SMM-13HQPS | Class I | Active |
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Manufacturer
- Manufacturer
- ClariPi Inc.
- EUDAMED SRN
- KR-MF-000031518
- Authorised Representative
- AR Experts B.V. NL-AR-000023989
Sources (2)
- EUDAMED 675045ad-bb7c-4eb8-b235-d99c7f476863 61 fields · synced Jul 14, 2026
- FDA 510(k) K203785 1 fields · synced May 18, 2026