Identity
- Trade Name
- eVu Senz App EUDAMEDFDA UDI
- Generic Name
- Psychophysiological biofeedback system FDA UDI
- Device Name
- eVu TPS System EUDAMED
- Model / Reference
- SA4502 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 07540191000487 EUDAMEDFDA UDI
- Basic UDI-DI
- 7540191000479H EUDAMED
- FDA Product Code
- HCC FDA UDI
- EMDN Code
- Z12062401 ELECTROMYOGRAPHIC BIOFEEDBACK SYSTEMS EUDAMED
- GMDN Term
- Psychophysiological biofeedback system FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 882.5050 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
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
eVu Senz App by Thought Technology Ltd. — 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 | 7540191000479H | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Thought Technology, Ltd.
- EUDAMED SRN
- CA-MF-000024010
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED b00baac1-893b-4ed0-b6bb-303b89572b82 61 fields · synced Jul 11, 2026
- FDA UDI 7cbef97e-ca43-4bd6-8e80-e04253735495 32 fields · synced May 30, 2026