Identity
- Trade Name
- αCare SENS EUDAMEDFDA UDI
- Generic Name
- Medical equipment clinical data interfacing software FDA UDI
- Device Name
- αCare SENS EUDAMED
- Model / Reference
- ACS-000000-00 EUDAMEDαCare SENS FDA UDI
Identifiers
- Catalog Number
- ACS-000000-00 FDA UDI
- Primary DI / UDI-DI
- 07290114061179 EUDAMEDFDA UDI
- Basic UDI-DI
- 729011406123ALCG4 EUDAMED
- FDA Product Code
- OUG FDA UDI
- EMDN Code
- N010199 NEUROPHYSIOLOGY DEVICES - OTHER EUDAMED
- GMDN Term
- Medical equipment clinical data interfacing software FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 880.6310 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
Yes
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
αCare SENS by Alpha Omega Engineering Ltd — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Manufacturer's product page: αCare-SENS
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 | 729011406123ALCG4 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Alpha Omega Engineering Ltd
- EUDAMED SRN
- IL-MF-000025214
- Authorised Representative
- Alpha Omega GmbH DE-AR-000022420
Sources (2)
- EUDAMED 9fd6ed7f-78a1-4201-afb5-38e2a31675dd 61 fields · synced Jul 8, 2026
- FDA UDI 922e2047-b12c-4194-9bfb-7d7b8a11dcdb 33 fields · synced May 30, 2026