Identity
- Trade Name
- NovaChat 10.6 EUDAMEDSaltillo FDA UDI
- Generic Name
- Voice synthesizer/digitizer FDA UDI
- Device Name
- NovaChat 5.4 EUDAMEDNova Chat 10.6 is a speech generating device with a 10 inch screen. NOVA chat 10 offers the well-known Chat Software on an Android platform. Like all "Chats," NOVA chat 10 offers a durable yet sleek portable design, with features that include a 10" display, switch scanning, Social Chat, IVONA speech synthesizer, and many other Chat features. Now also available in an Active case. FDA UDI
- Model / Reference
- NC5.4 EUDAMEDNC10.6 EUDAMEDFDA UDI
- Description
- Nova Chat 10.6 is a speech generating device with a 10 inch screen. NOVA chat 10 offers the well-known Chat Software on an Android platform. Like all "Chats," NOVA chat 10 offers a durable yet sleek portable design, with features that include a 10" display, switch scanning, Social Chat, IVONA speech synthesizer, and many other Chat features. Now also available in an Active case. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00816486020780 EUDAMEDFDA UDI
- Basic UDI-DI
- 81648602NovaChatMZ EUDAMED
- FDA Product Code
- ILQ FDA UDI
- EMDN Code
- Y214212 VOICE GENERATORS EUDAMED
- GMDN Term
- Voice synthesizer/digitizer FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 890.3710 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
NovaChat 10.6 by Prentke Romich Company — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 81648602NovaChatMZ | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Prentke Romich Company
- EUDAMED SRN
- US-MF-000018695
- Authorised Representative
- Prentke Romich GmbH DE-AR-000005106
Sources (2)
- EUDAMED 67785976-0701-4204-9e23-dda23bef889b 61 fields · synced Oct 6, 2026
- FDA UDI 0d229ae9-1d9b-493e-a00e-b55a05c2df98 34 fields · synced May 30, 2026