Identity
- Trade Name
- SimplyWorks Keyboards (no bundled receiver) EUDAMED
- Device Name
- KEYBOARDS EUDAMED
- Model / Reference
- SWKEY2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060895630992 EUDAMED
- Basic UDI-DI
- 506089563KEYBE6 EUDAMED
- Direct Marketing DI
- 05060895630992 EUDAMED
- EMDN Code
- Y210906 MOUSE AND KEYBOARD EMULATORS EUDAMED
Classification
- Device Class
- Class I 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
SimplyWorks Keyboards (no bundled receiver) by Pretorian Technologies Ltd — Class I — 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 | 506089563KEYBE6 | Class I | Active |
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Manufacturer
- Manufacturer
- Pretorian Technologies Ltd
- EUDAMED SRN
- GB-MF-000008344
- Authorised Representative
- European Healthcare & Device Solutions Ltd. IE-AR-000003999
Sources (1)
- EUDAMED 1bd64056-5249-4a5a-b71f-b9fffb004429 61 fields · synced Oct 6, 2026