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NovaChat 10.7 TouchGuide 25 Location
EUDAMEDFDA UDIClass I (EU MDR)
Ref 19584-25-AModel NC5.4
Identity
- Trade Name
- NovaChat 10.7 TouchGuide 25 Location EUDAMEDNovaChat FDA UDI
- Generic Name
- Voice synthesizer/digitizer FDA UDI
- Device Name
- NovaChat 5.4 EUDAMEDNovaChat 10.7 TouchGuide 25 Location FDA UDI
- Model / Reference
- NC5.4 EUDAMED19584-25-A EUDAMED19584-25 FDA UDI
- Description
- NovaChat 10.7 TouchGuide 25 Location FDA UDI
Identifiers
- Catalog Number
- NC10.7-25TG FDA UDI
- Primary DI / UDI-DI
- 00816486021329 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
NovaChat 10.7 TouchGuide 25 Location 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 7f5b5870-f8f7-4321-a625-b8c495c2549d 61 fields · synced Oct 6, 2026
- FDA UDI 2c135918-d2fa-4edc-b3f9-7202a9e4a2ca 35 fields · synced May 30, 2026