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QuickTalker Feather Touch 12
EUDAMEDFDA UDIClass I (EU MDR)
Ref 10000037
by AbleNet Inc.
Identity
- Trade Name
- QuickTalker Feather Touch 12 EUDAMEDQuickTalker FT 12 FDA UDI
- Generic Name
- Assistive speech generator FDA UDI
- Device Name
- QuickTalker FT - 12 EUDAMEDThe QuickTalker FeatherTouch 12 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 12 includes 48 unique messages available across five recording levels and provides an individual with robust communication options throughout the day. FDA UDI
- Model / Reference
- 10000037 EUDAMEDFDA UDI
- Description
- The QuickTalker FeatherTouch 12 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 12 includes 48 unique messages available across five recording levels and provides an individual with robust communication options throughout the day. FDA UDI
Identifiers
- Catalog Number
- 10000037 FDA UDI
- Primary DI / UDI-DI
- 00186648000807 EUDAMEDFDA UDI
- Basic UDI-DI
- 018664800010000037VV EUDAMED
- Direct Marketing DI
- 00186648000807 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 Feather Touch 12 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 | 018664800010000037VV | 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 3161a7be-fb40-4a5d-a177-c30151f3e0d2 61 fields · synced Oct 6, 2026
- FDA UDI 5dcb7689-cd3e-436b-a46b-dc63e35b59bd 34 fields · synced May 30, 2026