← Back to catalogue
Accent 1400 Thick Keyguard 84 Location
EUDAMEDFDA UDIClass I (EU MDR)
Ref 17342-84-XTModel ACN1000-40
Identity
- Trade Name
- Accent 1400 Thick Keyguard 84 Location EUDAMEDFDA UDI
- Generic Name
- Voice synthesizer/digitizer FDA UDI
- Device Name
- Accent 1000 EUDAMEDThe keyguard allows the Accent 1400 to be set up for specific locations to accommodate a wide range of cognitive and motor skills. Using the keyguard with the 1400 requires the device frame that came with the 1400. If a replacement frame is needed please go to 1400 Device Frame. FDA UDI
- Model / Reference
- ACN1000-40 EUDAMED17342-84-XT EUDAMEDFDA UDI
- Description
- The keyguard allows the Accent 1400 to be set up for specific locations to accommodate a wide range of cognitive and motor skills. Using the keyguard with the 1400 requires the device frame that came with the 1400. If a replacement frame is needed please go to 1400 Device Frame. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00858526006132 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Accent 1400 Thick Keyguard 84 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 | 81648602Accent8H | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Prentke Romich Company
- EUDAMED SRN
- US-MF-000018695
- Authorised Representative
- Prentke Romich GmbH DE-AR-000005106
Sources (2)
- EUDAMED e22679ac-85d1-4bb7-8ead-ce2ed535111f 61 fields · synced Jul 11, 2026
- FDA UDI d86b62fe-3b32-44ee-a88b-923276346593 34 fields · synced May 30, 2026