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X8 System (Sleep Profiler, Sleep Profiler PSG2)
EUDAMEDFDA UDIClass I (EU MDR)
Ref UN03-5204
Identity
- Trade Name
- X8 System (Sleep Profiler, Sleep Profiler PSG2) EUDAMEDX8 FDA UDI
- Generic Name
- Electrical-only medical device connection cable, reusable FDA UDI
- Device Name
- X8 System EUDAMEDExternal Battery Custom Cable Kit FDA UDI
- Model / Reference
- UN03-5204 EUDAMEDFDA UDI
- Description
- External Battery Custom Cable Kit FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00851113007185 EUDAMEDFDA UDI
- Basic UDI-DI
- 0851113007SP29ACCTH EUDAMED
- 510(k) Number
- K152040 FDA UDI
- FDA Product Code
- OLV FDA UDIOMC FDA UDI
- EMDN Code
- N01010203 EEG HEADSETS EUDAMED
- GMDN Term
- Electrical-only medical device connection cable, reusable FDA UDI
Classification
- Device Class
- Class I 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
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
Yes
FDA UDI
Serial Number
No
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 I — 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 | 0851113007SP29ACCTH | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | 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 99cf5dc2-7df2-48d4-8331-3108b709a864 61 fields · synced Oct 6, 2026
- FDA UDI e99c56db-d44f-4506-a64d-76a0b71645a6 34 fields · synced May 30, 2026