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Upgrade from Keypoint.NET to Natus Elite - Keypoint Master Software
EUDAMEDClass IIb (EU MDR)
Ref 688-630150
Identity
- Trade Name
- Upgrade from Keypoint.NET to Natus Elite - Keypoint Master Software EUDAMED
- Device Name
- Nicolet EDX EUDAMED
- Model / Reference
- 688-630150 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00382830044431 EUDAMED
- Basic UDI-DI
- 038283NA00151E9 EUDAMED
- EMDN Code
- Z12100482 ELECTROMYOGRAPHY INSTRUMENTS - SOFTWARE 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
Upgrade from Keypoint.NET to Natus Elite - Keypoint Master Software by Natus Neurology Incorporated — Class IIb — 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 | 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 4717c883-76bd-4c2c-a7f4-ec8a43b1fc76 61 fields · synced Oct 6, 2026