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QuickTalker FeatherTouch 7
EUDAMEDFDA UDIClass I (EU MDR)
Ref 10000036
by AbleNet Inc.
Identity
- Trade Name
- QuickTalker FeatherTouch 7 EUDAMEDQuickTalker FT 7 FDA UDI
- Generic Name
- Assistive speech generator FDA UDI
- Device Name
- QuickTalker FT 7 EUDAMEDThe QuickTalker FeatherTouch 7 speech device provides multi-message communication that is highly portable, durable, and easy to use. The FeatherTouch membrane responds to the lightest touches and smallest fingers, and makes it easy for almost anyone to communicate. QuickTalker FeatherTouch 7 includes 23 unique messages available across five recording levels and provides an individual with robust communication options throughout the day. FDA UDI
- Model / Reference
- 10000036 EUDAMEDFDA UDI
- Description
- The QuickTalker FeatherTouch 7 speech device provides multi-message communication that is highly portable, durable, and easy to use. The FeatherTouch membrane responds to the lightest touches and smallest fingers, and makes it easy for almost anyone to communicate. QuickTalker FeatherTouch 7 includes 23 unique messages available across five recording levels and provides an individual with robust communication options throughout the day. FDA UDI
Identifiers
- Catalog Number
- 10000036 FDA UDI
- Primary DI / UDI-DI
- 00186648000791 EUDAMEDFDA UDI
- Basic UDI-DI
- 018664800010000036VT EUDAMED
- Direct Marketing DI
- 00186648000791 EUDAMED
- FDA Product Code
- ILQ FDA UDI
- EMDN Code
- Y214212 VOICE GENERATORS EUDAMED
- GMDN Term
- Assistive speech generator 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
No
FDA UDI
Over-the-Counter
No
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
QuickTalker FeatherTouch 7 by AbleNet Inc. — 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 | 018664800010000036VT | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- AbleNet Inc.
- EUDAMED SRN
- US-MF-000008722
- Authorised Representative
- EUCEREP B.V. NL-AR-000001966
Sources (2)
- EUDAMED 8bbffc7f-25a7-43c7-91c0-f7592e7748ad 61 fields · synced Jun 19, 2026
- FDA UDI 751ad665-050b-428d-ba7e-74bcd5f5f558 34 fields · synced May 30, 2026