Identity
- Trade Name
- Natus Brain Monitor and Embla Dx EUDAMEDEmbla FDA UDI
- Generic Name
- Electroencephalograph FDA UDI
- Device Name
- Natus Brain Monitor Kit EUDAMEDNATUS EMBLA SDx FDA UDI
- Model / Reference
- 021920 EUDAMEDFDA UDI
- Description
- NATUS EMBLA SDx FDA UDI
Identifiers
- Catalog Number
- 021920 FDA UDI
- Primary DI / UDI-DI
- 00382830047241 EUDAMEDFDA UDI
- Basic UDI-DI
- 038283NA00153ED EUDAMED
- Direct Marketing DI
- 00382830047241 EUDAMED
- FDA Product Code
- GWQ FDA UDI
- EMDN Code
- Z12100302 ELECTROENCEPHALOGRAPHS EUDAMED
- GMDN Term
- Electroencephalograph FDA UDI
Classification
- Device Class
- Class IIa 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Natus Brain Monitor and Embla Dx 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 | 038283NA00153ED | 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 1516bbcf-cff9-4e45-8723-020418dc7935 61 fields · synced Oct 7, 2026
- FDA UDI 1ecc74a4-50d8-46fc-bc05-6b557cc4bc6d 35 fields · synced May 30, 2026