Night Shift
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Identity
- Trade Name
- Night Shift EUDAMEDFDA UDI
- Generic Name
- Behavioural therapy electrical stimulation system FDA UDI
- Device Name
- Night Shift EUDAMEDNight Shift LE Device Kit - Swiss FDA UDI
- Model / Reference
- NS27-1005.LE(SWISS) EUDAMEDFDA UDI
- Description
- Night Shift LE Device Kit - Swiss FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10850015266192 EUDAMEDFDA UDI
- Basic UDI-DI
- 0851113007NS27PN EUDAMED
- Direct Marketing DI
- 00850015266195 EUDAMED
- 510(k) Number
- K140190 FDA UDI
- FDA Product Code
- MYB FDA UDIMNR FDA UDI
- EMDN Code
- R9099 RESPIRATORY AND ANAESTHESIA DEVICES - OTHER EUDAMED
- GMDN Term
- Behavioural therapy electrical stimulation system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.5570 FDA UDI868.2375 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
Yes
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
No
Category: Pulmonary function analysis system, adult
Night Shift by Advanced Brain Monitoring, Inc. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
FDA_510K
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K140190 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 0851113007NS27PN | Class IIa | Active |
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Manufacturer
- Manufacturer
- Advanced Brain Monitoring, Inc.
- EUDAMED SRN
- US-MF-000011252
- Authorised Representative
- MPS Medical Product Service GmbH DE-AR-000005009
Sources (3)
- EUDAMED 173f0d64-5dbc-4f7b-a5e8-475e489c9b98 85 fields · synced Jun 18, 2026
- FDA UDI d44d99b1-00dd-4297-aafe-7598954b7a36 35 fields · synced May 30, 2026
- FDA 510(k) K140190 1 fields · synced May 18, 2026