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Natus Brain Monitor and Embla Dx
EUDAMEDClass IIa (EU MDR)
Ref PK1270Ref PK1245Ref 022343
Identity
- Trade Name
- Natus Brain Monitor and Embla Dx EUDAMED
- Device Name
- Natus Brain Monitor Kit EUDAMED
- Model / Reference
- PK1270 EUDAMEDPK1245 EUDAMED022343 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00382830048194 EUDAMED00382830048187 EUDAMED00382830048354 EUDAMED
- Basic UDI-DI
- 038283NA00153ED EUDAMED
- Direct Marketing DI
- 00382830048194 EUDAMED00382830048187 EUDAMED00382830048354 EUDAMED
- EMDN Code
- Z12100302 ELECTROENCEPHALOGRAPHS EUDAMED
Classification
- Device Class
- Class IIa 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
Natus Brain Monitor and Embla Dx by Natus Medical Incorporated Dba Excel-Tech Ltd (xltek) — Class IIa — 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 | 038283NA00153ED | Class IIa | Active |
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Manufacturer
- EUDAMED SRN
- CA-MF-000004001
- Authorised Representative
- Natus Manufacturing Ltd IE-AR-000000884
Sources (3)
- EUDAMED a67d085e-3393-42ea-9c01-7930d9bd5748 61 fields · synced Oct 6, 2026
- EUDAMED 4f8588ea-3a80-4b02-9dd7-efdf1a9c4801 61 fields · synced May 17, 2026
- EUDAMED 2180d39b-d12d-4961-bbaf-842410a26179 61 fields · synced May 19, 2026