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OptiPlex 7000 - Incl Win10 Pro - Labeled - English (MUI)
EUDAMEDClass IIa (EU MDR)
Ref 031637
Identity
- Trade Name
- OptiPlex 7000 - Incl Win10 Pro - Labeled - English (MUI) EUDAMED
- Device Name
- Dantec Keypoint Focus EUDAMED
- Model / Reference
- 031637 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00382830062435 EUDAMED
- Basic UDI-DI
- 038283NA00154EF EUDAMED
- Direct Marketing DI
- 00382830062435 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
OptiPlex 7000 - Incl Win10 Pro - Labeled - English (MUI) 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 44d218ed-b220-499a-a291-cc41460169b2 61 fields · synced Jul 13, 2026