Identity
- Trade Name
- Specs IC EUDAMEDFDA UDI
- Generic Name
- Assistive speech generator FDA UDI
- Device Name
- Specs IC EUDAMEDWith a 1 3/8-in/3.5-cm activation surface, the Specs switch is small enough to be worn, but is most often used as a mounted switch. The Specs switch includes a space saving flush base and a strap base for mounting around items. 24-inch strap included. FDA UDI
- Model / Reference
- 10000114 EUDAMEDFDA UDI
- Description
- With a 1 3/8-in/3.5-cm activation surface, the Specs switch is small enough to be worn, but is most often used as a mounted switch. The Specs switch includes a space saving flush base and a strap base for mounting around items. 24-inch strap included. FDA UDI
Identifiers
- Catalog Number
- 10000114 FDA UDI
- Primary DI / UDI-DI
- 00850011150382 EUDAMEDFDA UDI
- Basic UDI-DI
- 085001115010000114EA EUDAMED
- Direct Marketing DI
- 00850011150382 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
Specs IC 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 | 085001115010000114EA | 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 4d7c2737-ea67-4094-9e0d-faab5d22bf1a 61 fields · synced Oct 6, 2026
- FDA UDI f5b9de54-5ba5-4ebf-b736-17bde8969faa 34 fields · synced May 29, 2026