Identity
- Trade Name
- Viking EDX International EUDAMED
- Device Name
- Nicolet EDX EUDAMED
- Model / Reference
- 982A0568 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00382830032896 EUDAMED
- Basic UDI-DI
- 038283NA00151E9 EUDAMED
- EMDN Code
- Z12100401 ELECTROMYOGRAPHS 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
Viking EDX International 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 71a1eb46-b970-41aa-8cb9-150f585cf776 61 fields · synced Jun 19, 2026