Identity
- Trade Name
- Original Receiver EUDAMEDWireless Receiver FDA UDI
- Generic Name
- Assistive electronic switch FDA UDI
- Device Name
- Original Receiver EUDAMED
- Model / Reference
- 10034400 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- 10034400 FDA UDI
- Primary DI / UDI-DI
- 00186648000715 EUDAMEDFDA UDI
- Basic UDI-DI
- 018664800010034400XP EUDAMED
- Direct Marketing DI
- 00186648000715 EUDAMED
- FDA Product Code
- KNO FDA UDI
- EMDN Code
- Y210999,Y214299,Y240999,Y241899 EUDAMED
- GMDN Term
- Assistive electronic switch 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
Original Receiver 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 | 018664800010034400XP | 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 a31097c3-e5d8-48d7-b6ce-36a00d391fbe 61 fields · synced Jun 19, 2026
- FDA UDI 39504f2b-6236-47d9-9993-d49b38a9d1a8 33 fields · synced May 30, 2026