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X8 System (Sleep Profiler, Sleep Profiler PSG2)
EUDAMEDClass I (EU MDR)
Ref SP40-4101.50
Identity
- Trade Name
- X8 System (Sleep Profiler, Sleep Profiler PSG2) EUDAMED
- Device Name
- X8 System EUDAMED
- Model / Reference
- SP40-4101.50 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 20851113007219 EUDAMED
- Basic UDI-DI
- 0851113007SP29ACCTH EUDAMED
- EMDN Code
- N01010203 EEG HEADSETS EUDAMED
Classification
- Device Class
- Class I 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
X8 System (Sleep Profiler, Sleep Profiler PSG2) by Advanced Brain Monitoring, Inc. — Class I — 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 | 0851113007SP29ACCTH | Class I | 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 d3d5a98f-d02d-4b23-b3aa-5f94721d0d3a 61 fields · synced Oct 9, 2026