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NightOwl Software
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref 05430001742152
by Ectosense nv
Identity
- Device Name
- NightOwl Software EUDAMED
- Model / Reference
- 05430001742152 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05430001742152 EUDAMED
- Basic UDI-DI
- 5430001742NOSXL EUDAMED
- EMDN Code
- V92 MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
NightOwl Software by Ectosense nv — 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
United States Active
FDA_510K
United States Active
FDA_510K
European Union No Longer Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K191031 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K213463 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K220028 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 5430001742NOSXL | Class IIa | No Longer Active |
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Manufacturer
- Manufacturer
- Ectosense nv
- EUDAMED SRN
- BE-MF-000025111
Sources (2)
- EUDAMED 550df2de-4b02-467d-96ed-92f9c2f1bc50 61 fields · synced Jun 19, 2026
- FDA 510(k) K191031 1 fields · synced May 18, 2026