Identity
- Trade Name
- EDX Laptop PC, German EUDAMED
- Device Name
- Nicolet EDX EUDAMED
- Model / Reference
- 842-689900DE EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00382830059565 EUDAMED
- Basic UDI-DI
- 038283NA00151E9 EUDAMED
- Direct Marketing DI
- 00382830059565 EUDAMED
- EMDN Code
- Z12100480 ELECTROMYOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIb 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
EDX Laptop PC, German by Natus Neurology Incorporated — Class IIb — 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 | 038283NA00151E9 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Natus Neurology Incorporated
- EUDAMED SRN
- US-MF-000004246
- Authorised Representative
- Natus Manufacturing Ltd IE-AR-000000884
Sources (1)
- EUDAMED ec7bc0a4-e59c-442a-ae23-06bd8bacb516 61 fields · synced Oct 6, 2026