Identity
- Trade Name
- Quantum Breakout Roll stand EUDAMEDNatus FDA UDI
- Generic Name
- Electroencephalographic monitoring system FDA UDI
- Device Name
- Quantum II Class I Accessories EUDAMEDQuantum Breakout Roll Stand FDA UDI
- Model / Reference
- 017264 EUDAMEDFDA UDI
- Description
- Quantum Breakout Roll Stand FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00382830059305 EUDAMEDFDA UDI
- Basic UDI-DI
- 038283NA00058EJ EUDAMED
- Direct Marketing DI
- 00382830059305 EUDAMED
- FDA Product Code
- GXY FDA UDI
- EMDN Code
- Z12100380 ELECTROENCEPHALOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Electroencephalographic monitoring system FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 882.1320 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Quantum Breakout Roll stand by Natus Medical Incorporated Dba Excel-Tech Ltd (xltek) — Class I — 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 | 038283NA00058EJ | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- EUDAMED SRN
- CA-MF-000004001
- Authorised Representative
- Natus Manufacturing Ltd IE-AR-000000884
Sources (2)
- EUDAMED 6ced89a5-28f8-4628-b11b-f9d643d19b27 61 fields · synced Jun 19, 2026
- FDA UDI cef78a68-0a9a-420d-b364-b73b80e7ab23 33 fields · synced May 30, 2026