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X8 System (Sleep Profiler, Sleep Profiler PSG2)
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref SP40-4225.1
Identity
- Trade Name
- X8 System (Sleep Profiler, Sleep Profiler PSG2) EUDAMEDSleep Profiler FDA UDI
- Generic Name
- Patient monitoring system module, electroencephalographic FDA UDI
- Device Name
- X8 System EUDAMEDSleep Profiler Strip Kit FDA UDI
- Model / Reference
- SP40-4225.1 EUDAMEDFDA UDI
- Description
- Sleep Profiler Strip Kit FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00851113007222 EUDAMEDFDA UDI
- Basic UDI-DI
- 0851113007SP29QE EUDAMED
- FDA Product Code
- OLV FDA UDIOMC FDA UDI
- EMDN Code
- N01010203 EEG HEADSETS EUDAMED
- GMDN Term
- Patient monitoring system module, electroencephalographic FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 882.1400 FDA UDI
- Market of Registration
- Ireland 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
No
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
Yes
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
X8 System (Sleep Profiler, Sleep Profiler PSG2) by Advanced Brain Monitoring, Inc. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0851113007SP29QE | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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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 (2)
- EUDAMED 12b81167-c4ad-41f1-a925-40c718612059 61 fields · synced Oct 7, 2026
- FDA UDI 0b2ba161-7e23-4368-b415-c6155623519c 34 fields · synced May 30, 2026