Identity
- Trade Name
- Smooth Talker Green EUDAMED
- Device Name
- AAC Devices EUDAMED
- Model / Reference
- Smooth Talker Green EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060895630022 EUDAMED
- Basic UDI-DI
- 506089563AAC18A EUDAMED
- Direct Marketing DI
- 05060895630022 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 Green 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 d2c8423d-6b3d-4bee-bb31-83fd710fdc75 61 fields · synced Oct 6, 2026