Identity
- Trade Name
- Smoothie 125 Blue (Large Jack) EUDAMED
- Device Name
- Assistive Switches EUDAMED
- Model / Reference
- SMOO5LJB EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060895630848 EUDAMED
- Basic UDI-DI
- 506089563SWS1H6 EUDAMED
- Direct Marketing DI
- 05060895630848 EUDAMED
- EMDN Code
- Y210999,Y214299,Y240999,Y241899 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
Smoothie 125 Blue (Large Jack) 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 | 506089563SWS1H6 | 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 2a65ac42-a461-4339-9348-7e19c8d447c4 61 fields · synced Oct 6, 2026