Identity
- Trade Name
- MyOnyx Mobile App EUDAMEDFDA UDI
- Generic Name
- Psychophysiological biofeedback system FDA UDI
- Device Name
- MyOnyx Mobile App EUDAMED
- Model / Reference
- SA9030 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 07540191000586 EUDAMEDFDA UDI
- Basic UDI-DI
- B-07540191000586 EUDAMED
- FDA Product Code
- KPI FDA UDIHCC FDA UDIIPF FDA UDIGZJ FDA UDI
- EMDN Code
- N01028099,U070399,Z12062492,Z12062892 EUDAMED
- GMDN Term
- Psychophysiological biofeedback system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 876.5320 FDA UDI882.5050 FDA UDI890.5850 FDA UDI882.5890 FDA UDI
- Special Device Type
- -1192 EUDAMED
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Physical therapy transcutaneous neuromuscular electrical stimulation systemPsychophysiological biofeedback systemPerineal orifice incontinence-control electrical stimulation system probe, reusable
MyOnyx Mobile App by Thought Technology Ltd. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Thought Technology Ltd.
Sources (2)
- FDA UDI adb579b3-a841-43c3-a2b9-6a398b5f03aa 33 fields · synced Jul 17, 2026
- EUDAMED ac041551-37f3-4126-8dee-a2e965f77cef 61 fields · synced Jul 17, 2026