Identity
- Trade Name
- Keypoint Focus Notebook System, NLD EUDAMED
- Device Name
- Dantec Keypoint Focus EUDAMED
- Model / Reference
- 9033A071105 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00382830050012 EUDAMED
- Basic UDI-DI
- 038283NA00154EF EUDAMED
- EMDN Code
- N010199 NEUROPHYSIOLOGY DEVICES - OTHER 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
Keypoint Focus Notebook System, NLD by Natus Manufacturing Limited — Class IIa — 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 | 038283NA00154EF | Class IIa | Active |
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Manufacturer
- Manufacturer
- Natus Manufacturing Limited
- EUDAMED SRN
- IE-MF-000000799
Sources (1)
- EUDAMED 209a639f-863a-4b6c-a5f0-44f9b8d70c91 61 fields · synced Jun 20, 2026