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X8 System (Sleep Profiler, Sleep Profiler PSG2)
EUDAMEDClass IIa (EU MDR)
Ref 29-1001
Identity
- Trade Name
- X8 System (Sleep Profiler, Sleep Profiler PSG2) EUDAMED
- Device Name
- X8 System EUDAMED
- Model / Reference
- 29-1001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00851113007154 EUDAMED
- Basic UDI-DI
- 0851113007SP29QE EUDAMED
- Direct Marketing DI
- 00851113007154 EUDAMED
- EMDN Code
- N01010203 EEG HEADSETS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Ireland 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
X8 System (Sleep Profiler, Sleep Profiler PSG2) by Advanced Brain Monitoring, Inc. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0851113007SP29QE | 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 (1)
- EUDAMED 0f5e913d-8773-4b08-93b8-ef2ee7d29520 61 fields · synced Jun 18, 2026