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Accent 800 Keyguard 28 Location
EUDAMEDFDA UDIClass I (EU MDR)
Ref 17348-28Model ACN1000-40
Identity
- Trade Name
- Accent 800 Keyguard 28 Location EUDAMEDFDA UDI
- Generic Name
- Voice synthesizer/digitizer FDA UDI
- Device Name
- Accent 1000 EUDAMEDKeyguards are made from thick, clear polycarbonate material and precisely engineered to help guide the user’s touch to targeted icons on the screen and reduce accidental activations. Keyguards allow the Accent 800/800-D to be set up to accommodate a wide range of cognitive and motor skills. Using the Keyguard with the 800 requires the device frame that came with the 800. If a replacement frame is needed please go to (insert link to 800 Device Frame) These keyguards have rectangular openings as shown in the picture and are made from clear .183" thick polycarbonate. FDA UDI
- Model / Reference
- ACN1000-40 EUDAMED17348-28 EUDAMEDFDA UDI
- Description
- Keyguards are made from thick, clear polycarbonate material and precisely engineered to help guide the user’s touch to targeted icons on the screen and reduce accidental activations. Keyguards allow the Accent 800/800-D to be set up to accommodate a wide range of cognitive and motor skills. Using the Keyguard with the 800 requires the device frame that came with the 800. If a replacement frame is needed please go to (insert link to 800 Device Frame) These keyguards have rectangular openings as shown in the picture and are made from clear .183" thick polycarbonate. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00858526006514 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 800 Keyguard 28 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 |
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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 b5a84ee3-6262-4853-8b13-89ee58e3b3d3 61 fields · synced Oct 6, 2026
- FDA UDI c854fa93-1ee4-4467-a8c9-110a5d816433 34 fields · synced May 30, 2026