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Keypoint Focus Notebook System, ITA
EUDAMEDClass IIa (EU MDR)
Ref 9033A071106Ref 9033A07N-ITA
Identity
- Trade Name
- Keypoint Focus Notebook System, ITA EUDAMEDNATUS KEYPOINT FOCUS NOTEBOOK SYSTEM, ITA EUDAMED
- Device Name
- Dantec Keypoint Focus EUDAMEDNatus Keypoint EUDAMED
- Model / Reference
- 9033A071106 EUDAMED9033A07N-ITA EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00382830050029 EUDAMED00382830063388 EUDAMED
- Basic UDI-DI
- 038283NA00154EF EUDAMED038283NA00166EN 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, ITA 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 (2)
- EUDAMED 9a956bc8-98a2-4f51-abf1-512b8b5b4b3c 61 fields · synced Aug 2, 2026
- EUDAMED cace4080-9639-4830-83df-27ca21ec32df 61 fields · synced May 19, 2026