Identity
- Trade Name
- Accent 800 EUDAMEDFDA UDI
- Generic Name
- Voice synthesizer/digitizer FDA UDI
- Device Name
- Accent 1000 EUDAMEDAccent® 800 is an integrated speech device and offers advanced functionality and user-friendly features. It is the smallest and most portable PRC device that offers a variety of vocabulary options. The Accent 800 offers a choice of vocabulary options featuring Unity® with LAMP/Words for Life™, CoreScanner™, and WordCore. Other available vocabulary options include Essence™ for literate adults and WordPower™. The Accent 800 is powered by PRC’s NuVoice™ software and offers built in support resources for clinicians and clients. FDA UDI
- Model / Reference
- ACN1000-40 EUDAMEDACN800-40 EUDAMEDFDA UDI
- Description
- Accent® 800 is an integrated speech device and offers advanced functionality and user-friendly features. It is the smallest and most portable PRC device that offers a variety of vocabulary options. The Accent 800 offers a choice of vocabulary options featuring Unity® with LAMP/Words for Life™, CoreScanner™, and WordCore. Other available vocabulary options include Essence™ for literate adults and WordPower™. The Accent 800 is powered by PRC’s NuVoice™ software and offers built in support resources for clinicians and clients. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00858526006743 EUDAMEDFDA UDI
- Basic UDI-DI
- 81648602Accent8H 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
Dimensions & Sizes
- Size
- Weight — 2.45 Pound FDA UDI
Accent 800 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 | 81648602Accent8H | 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 4a30b18d-0bff-41cf-b107-5178f099f5ad 61 fields · synced May 30, 2026
- FDA UDI 532934e4-cb44-4308-bf28-94ce5e014e1b 36 fields · synced May 30, 2026