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LITTLE Step-by-Step
EUDAMEDFDA UDIClass I (EU MDR)
Ref 10000044
by AbleNet Inc.
Identity
- Trade Name
- LITTLE Step-by-Step EUDAMEDFDA UDI
- Generic Name
- Assistive speech generator FDA UDI
- Device Name
- LITTLE Step-by-Step EUDAMED
- Model / Reference
- 10000044 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- 10000044 FDA UDI
- Primary DI / UDI-DI
- 00850011150092 EUDAMEDFDA UDI
- Basic UDI-DI
- 085001115010000044EE EUDAMED
- Direct Marketing DI
- 00850011150092 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
LITTLE Step-by-Step 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 | 085001115010000044EE | 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 600c00bd-447f-40f0-b220-74a88737ab13 61 fields · synced Oct 6, 2026
- FDA UDI 7c654182-12d0-4029-9cc0-41f03002cc09 33 fields · synced May 29, 2026