Identity
- Trade Name
- TalkingBrix 2 EUDAMEDFDA UDI
- Generic Name
- Assistive speech generator FDA UDI
- Device Name
- TalkingBrix 2 EUDAMEDExpand your communication options with a set of three TalkingBrix 2 speech devices. Pressing the colored top plays a single message up to 10-seconds long. Use individually or connect to make a multi-message speech device. Includes ableCARE on-demand support Built ableSTRONG to endure drops and other environmental conditions Made from ableSAFE materials and tested by third-party safety labs Common Uses Add strategically around the classroom or home to provide on-the-spot communication Use together to make choices Use with multiple individuals at one time to provide each with a unique communication message Features High-quality sound suitable for almost any environment Long-lasting rechargeable battery Clear snap cover to attach picture symbols and provide communication context to the user Symbol Overlays Symbol overlays are not included with the TalkingBrix2. Download the free AbleNet Symbol Overlay app for iPad to create symbol overlays for your AbleNet speech device. FDA UDI
- Model / Reference
- 10000032 EUDAMEDFDA UDI
- Description
- Expand your communication options with a set of three TalkingBrix 2 speech devices. Pressing the colored top plays a single message up to 10-seconds long. Use individually or connect to make a multi-message speech device. Includes ableCARE on-demand support Built ableSTRONG to endure drops and other environmental conditions Made from ableSAFE materials and tested by third-party safety labs Common Uses Add strategically around the classroom or home to provide on-the-spot communication Use together to make choices Use with multiple individuals at one time to provide each with a unique communication message Features High-quality sound suitable for almost any environment Long-lasting rechargeable battery Clear snap cover to attach picture symbols and provide communication context to the user Symbol Overlays Symbol overlays are not included with the TalkingBrix2. Download the free AbleNet Symbol Overlay app for iPad to create symbol overlays for your AbleNet speech device. FDA UDI
Identifiers
- Catalog Number
- 10000032 FDA UDI
- Primary DI / UDI-DI
- 00186648000524 EUDAMEDFDA UDI
- Basic UDI-DI
- 018664800010000032VK EUDAMED
- Direct Marketing DI
- 00186648000524 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
TalkingBrix 2 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 | 018664800010000032VK | 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
- AbleNet Inc.
- EUDAMED SRN
- US-MF-000008722
- Authorised Representative
- EUCEREP B.V. NL-AR-000001966
Sources (2)
- EUDAMED d5b4abd7-9069-41ce-aae2-9227f619f2e3 61 fields · synced Jun 18, 2026
- FDA UDI 5a2f15c8-29ab-4550-b6e7-644f58c6dd06 34 fields · synced May 30, 2026