Identity
- Trade Name
- NightOwl FDA UDI
- Generic Name
- Home-use sleep apnoea recording system FDA UDI
- Device Name
- NightOwl Sensor EUDAMED
- Model / Reference
- 7079589 EUDAMEDMini FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05430001742039 EUDAMEDFDA UDI
- Basic UDI-DI
- 5430001742NORXJ EUDAMED
- Direct Marketing DI
- 05430001742039 EUDAMED
- 510(k) Number
- K191031 FDA UDI
- FDA Product Code
- MNR FDA UDI
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
- GMDN Term
- Home-use sleep apnoea recording system FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 868.2375 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
Yes
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
NightOwl Sensor by Ectosense nv — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union No Longer Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 5430001742NORXJ | Class I | No Longer Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Ectosense nv
- EUDAMED SRN
- BE-MF-000025111
Sources (2)
- EUDAMED 7c1f2e17-afae-4bfd-a1b7-8084575736f6 61 fields · synced Jun 18, 2026
- FDA UDI 99c201a3-7fd4-4335-8690-422e64f9b0ac 33 fields · synced May 30, 2026