Identity
- Trade Name
- Unity AAC App EUDAMED
- Device Name
- TouchChat HD w/ WordPower App EUDAMED
- Model / Reference
- 00816486021015 EUDAMED20425 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00816486021626 EUDAMED
- Basic UDI-DI
- 81648602iOSSGDAppLX EUDAMED
- EMDN Code
- Y214212 VOICE GENERATORS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- Austria 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
Unity AAC App by Prentke Romich Company — 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 | 81648602iOSSGDAppLX | Class I | Active |
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Manufacturer
- Manufacturer
- Prentke Romich Company
- EUDAMED SRN
- US-MF-000018695
- Authorised Representative
- Prentke Romich GmbH DE-AR-000005106
Sources (1)
- EUDAMED d2520337-9fa1-48a4-9918-f80a5f075ef2 61 fields · synced Jun 18, 2026