Identity
- Trade Name
- Smooth Talker Yellow EUDAMED
- Device Name
- AAC Devices EUDAMED
- Model / Reference
- Smooth Talker Yellow EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060895630015 EUDAMED
- Basic UDI-DI
- 506089563AAC18A EUDAMED
- Direct Marketing DI
- 05060895630015 EUDAMED
- EMDN Code
- Y2199 COMMUNICATION AND INFORMATION MANAGEMENT AIDS - OTHER 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
Smooth Talker Yellow 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 | 506089563AAC18A | 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 05030eb7-2901-4f24-bf48-78fcb3bafea2 61 fields · synced Jun 18, 2026