Identity
- Trade Name
- Olympic Brainz Monitor(OBM) EUDAMEDXltek FDA UDI
- Generic Name
- Electroencephalograph FDA UDI
- Device Name
- OBM Viewer CD - V3.1.5 EUDAMEDOBM Viewer FDA UDI
- Model / Reference
- OBM00461 EUDAMEDFDA UDI
- Description
- OBM Viewer FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00382830057745 EUDAMEDFDA UDI
- Basic UDI-DI
- 038283NA00019E8 EUDAMED
- Direct Marketing DI
- 00382830057745 EUDAMED
- FDA Product Code
- OMA FDA UDI
- EMDN Code
- Z12100392 ELECTROENCEPHALOGRAPHY INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
- GMDN Term
- Electroencephalograph FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 882.1400 FDA UDI
- Special Device Type
- Software EUDAMED
- 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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Olympic Brainz Monitor(OBM) by Natus Medical Incorporated Dba Excel-Tech Ltd (xltek) — 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 | 038283NA00019E8 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- EUDAMED SRN
- CA-MF-000004001
- Authorised Representative
- Natus Manufacturing Ltd IE-AR-000000884
Sources (2)
- EUDAMED 05e52486-56c6-469d-9192-3d0b2bcc2ba6 61 fields · synced Oct 6, 2026
- FDA UDI b57c0e4b-c34d-462b-82c0-2cf5bdfd219f 33 fields · synced May 30, 2026