Identity
- Trade Name
- Quantum II, Main Breakout 2 Assembly EUDAMED
- Device Name
- Quantum (Phase II) 64-channel Breakout EUDAMED
- Model / Reference
- 016864 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00382830051682 EUDAMED
- Basic UDI-DI
- 038283NA00152EB EUDAMED
- Direct Marketing DI
- 00382830051682 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
Quantum II, Main Breakout 2 Assembly by Natus Medical Incorporated Dba Excel-Tech Ltd (xltek) — Class IIa — MDR — listed in EUDAMED
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 | 038283NA00152EB | Class IIa | Active |
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Manufacturer
- EUDAMED SRN
- CA-MF-000004001
- Authorised Representative
- Natus Manufacturing Ltd IE-AR-000000884
Sources (1)
- EUDAMED a0730bb7-f42d-45fa-84c6-1c7c644ff779 61 fields · synced Oct 6, 2026