Identity
- Trade Name
- Natus Quantum EUDAMEDNatus FDA UDI
- Generic Name
- Electroencephalograph FDA UDI
- Device Name
- Quantum (Phase II) 64-channel Breakout EUDAMEDBulk Connector Pin Box Assy 3 FDA UDI
- Model / Reference
- 016271 EUDAMEDFDA UDI
- Description
- Bulk Connector Pin Box Assy 3 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00382830016711 EUDAMEDFDA UDI
- Basic UDI-DI
- 038283NA00152EB EUDAMED
- Direct Marketing DI
- 00382830016711 EUDAMED
- 510(k) Number
- K143440 FDA UDI
- 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 Quantum by Natus Medical Incorporated Dba Excel-Tech Ltd (xltek) — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 038283NA00152EB | 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 bc951fe5-7410-416a-b758-2eabd7942659 61 fields · synced Jul 8, 2026
- FDA UDI 3172f671-a7b4-43a7-b72a-e1f32ea3a8b9 34 fields · synced May 29, 2026