Identity
- Trade Name
- Nova Chat FDA UDI
- Generic Name
- Voice synthesizer/digitizer FDA UDI
- Device Name
- 15 Location Keyguard for Nova Chat 10.4 FDA UDI
- Model / Reference
- NC10.4-15-KG FDA UDI
- Description
- 15 Location Keyguard for Nova Chat 10.4 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00816486020308 FDA UDI
- FDA Product Code
- ILQ FDA UDI
- GMDN Term
- Voice synthesizer/digitizer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.3710 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Voice synthesizer/digitizer
Nova Chat by Prentke Romich Company — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Prentke Romich Company
Sources (2)
- FDA UDI 7ceb6851-3f03-404f-805e-7cc6986602a4 34 fields · synced Jun 20, 2026
- EUDAMED 1 fields · synced May 29, 2026