Identity
- Trade Name
- BIG Candy Corn 2 EUDAMEDFDA UDI
- Generic Name
- Assistive speech generator FDA UDI
- Device Name
- BIG Candy Corn 2 EUDAMEDThe BIG Candy Corn 2 accessibility switch uses highly sensitive proximity sensor technology for activation. Anytime the user is near or touching the activation surface, the BIG Candy Corn 2 will activate. Individuals with fine motor impairments or low vision prefer the BIG Candy Corn 2 over the LITTLE Candy Corn because it has an activation surface nearly twice the size. Now powered by 2 AA batteries, the BIG Candy Corn 2 delivers twice the battery life of the original model, ensuring longer-lasting performance. When activated, an auditory beep and light provide feedback, which can be turned off if not needed. FDA UDI
- Model / Reference
- 10000077 EUDAMEDFDA UDI
- Description
- The BIG Candy Corn 2 accessibility switch uses highly sensitive proximity sensor technology for activation. Anytime the user is near or touching the activation surface, the BIG Candy Corn 2 will activate. Individuals with fine motor impairments or low vision prefer the BIG Candy Corn 2 over the LITTLE Candy Corn because it has an activation surface nearly twice the size. Now powered by 2 AA batteries, the BIG Candy Corn 2 delivers twice the battery life of the original model, ensuring longer-lasting performance. When activated, an auditory beep and light provide feedback, which can be turned off if not needed. FDA UDI
Identifiers
- Catalog Number
- 10000077 FDA UDI
- Primary DI / UDI-DI
- 00850011150344 EUDAMEDFDA UDI
- Basic UDI-DI
- 085001115010000077EV EUDAMED
- Direct Marketing DI
- 00850011150344 EUDAMED
- FDA Product Code
- ILQ FDA UDI
- EMDN Code
- Y210999,Y214299,Y240999,Y241899 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
- Netherlands 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
BIG Candy Corn 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 | 085001115010000077EV | 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 965389d5-6f71-4e64-8924-f17598560983 61 fields · synced Jun 18, 2026
- FDA UDI 294aa717-ebdc-4b37-90c9-b430be3490e2 34 fields · synced May 30, 2026