Identity
- Trade Name
- Blue2 FT EUDAMEDFDA UDI
- Generic Name
- Assistive human interface device proximal control, hand-operated FDA UDI
- Device Name
- Blue2 FT EUDAMED
- Model / Reference
- 10000053 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- 10000053 FDA UDI
- Primary DI / UDI-DI
- 00850011150276 EUDAMEDFDA UDI
- Basic UDI-DI
- 00850011150100000539R EUDAMED
- Direct Marketing DI
- 00850011150276 EUDAMED
- FDA Product Code
- KNO FDA UDI
- EMDN Code
- Y210999 PERSONAL COMPUTER INPUT AND OUTPUT PERIPHERAL EQUIPMENT - OTHER EUDAMED
- GMDN Term
- Assistive human interface device proximal control, hand-operated FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.3910 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
Blue2 FT 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 | 00850011150100000539R | 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 bf89b152-cd02-4582-bae5-d17e85ece457 61 fields · synced Jul 9, 2026
- FDA UDI e6fc3ec3-e460-4436-b583-0675b26c76a1 33 fields · synced May 29, 2026