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Neowise
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref NEOWISEModel Medical Device Software
by CEFLA s.c.
Identity
- Trade Name
- Neowise EUDAMED
- Model / Reference
- Medical Device Software EUDAMEDNEOWISE EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08033837938835 EUDAMED
- Basic UDI-DI
- 803383793IMSWASMDB001K8 EUDAMED
- Direct Marketing DI
- 08033837938835 EUDAMED
- EMDN Code
- Z11039092 VARIOUS RADIODIAGNOSTIC AND INTERVENTIONAL INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- Italy 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
Neowise by CEFLA s.c. — 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
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K260716 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 803383793IMSWASMDB001K8 | Class IIa | Active |
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Manufacturer
- Manufacturer
- CEFLA s.c.
- EUDAMED SRN
- IT-MF-000009228
Sources (2)
- EUDAMED 0c0434cb-c5de-4bdb-8037-fe98e3370c7a 61 fields · synced Jul 27, 2026
- FDA 510(k) K260716 1 fields · synced May 21, 2026