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Olympic Brainz Monitor(OBM)
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref OBM00462Ref OBM00401
Identity
- Trade Name
- Olympic Brainz Monitor(OBM) EUDAMEDNatus FDA UDI
- Generic Name
- Electroencephalograph FDA UDI
- Device Name
- OBM Viewer CD - V3.1.5 EUDAMEDOBM Main Unit - V3.1.5 FDA UDI
- Model / Reference
- OBM00462 EUDAMEDOBM00401 EUDAMEDFDA UDI
- Description
- OBM Main Unit - V3.1.5 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00382830057752 EUDAMED00382830010924 EUDAMEDFDA UDI
- Basic UDI-DI
- 038283NA00019E8 EUDAMED
- Direct Marketing DI
- 00382830057752 EUDAMED00382830010924 EUDAMED
- FDA Product Code
- OMC FDA UDIOMB FDA UDI
- EMDN Code
- Z12100382 ELECTROENCEPHALOGRAPHY INSTRUMENTS - SOFTWARE ACCESSORIES 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Olympic Brainz Monitor(OBM) by Natus Medical Incorporated Dba Excel-Tech Ltd (xltek) — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K123079 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 038283NA00019E8 | Class IIa | Active |
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Manufacturer
- EUDAMED SRN
- CA-MF-000004001
- Authorised Representative
- Natus Manufacturing Ltd IE-AR-000000884
Sources (4)
- EUDAMED a820fd82-2b57-4acd-8dec-efdc019a82b0 61 fields · synced Oct 6, 2026
- EUDAMED 5eca79b2-3a76-4f00-9bfc-ae03607c6185 61 fields · synced May 18, 2026
- FDA UDI 66be460c-696d-484e-aa92-902e74eb59da 33 fields · synced May 29, 2026
- FDA 510(k) K123079 1 fields · synced May 18, 2026