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CINA-iPE
EUDAMEDFDA 510(k)Class IIb (EU MDR)
Ref CINA-iPE510(k) K233968
by Avicenna.AI
Identity
- Trade Name
- CINA-iPE EUDAMED
- Device Name
- CINA-iPE EUDAMED
- Model / Reference
- CINA-iPE EUDAMED
Identifiers
- Primary DI / UDI-DI
- +B826CINAIPE100 EUDAMED
- Basic UDI-DI
- ++B826CINAIPE103M EUDAMED
- EMDN Code
- Z11039092 VARIOUS RADIODIAGNOSTIC AND INTERVENTIONAL INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- France 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
CINA-iPE by Avicenna.ai — Class IIb — 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 | K233968 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | ++B826CINAIPE103M | Class IIb | Active |
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Manufacturer
- Manufacturer
- Avicenna.AI
- EUDAMED SRN
- FR-MF-000000324
Sources (2)
- EUDAMED 7269111f-d0df-47d9-81dd-8c3cbcbf910a 85 fields · synced Jun 18, 2026
- FDA 510(k) K233968 1 fields · synced May 18, 2026